Global Regulatory Affairs Resume Sample
Birdie Hoppe
8564 Granville Landing,
Boston,
MA
+1 (555) 461 4268
Work Experience
Director, Global Regulatory Affairs
06/2015
-
PRESENT
Philadelphia, PA
- Ensure the execution of regional regulatory plans in line with the product’s global registration strategy in collaboration with the global regulatory leader
- Independently supports departmental operational activities utilizing advanced competencies, knowledge and judgment; proactively identifies and resolves complex issues using experience with guidance and support from the GRACS leadership team and colleagues within and external to GRACS, as needed
- Serves as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge. Applies capabilities to enhance quality and builds capabilities of less experienced staff, as appropriate
- Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Good Regulatory Practice, Good Pharmacovigilance Practice, and Good Clinical Practice), safety guidelines and company policies and procedures
- Collaborates effectively across areas within GRACS and partnering organizations to achieve quality goals
- Strong experience in pharmaceutical/biologics regulatory, legal, scientific, medical, or marketing disciplines
- Experience in International CMLR review and approval process of pharmaceutical/biologics promotion
- Understand EFPIA and International (ex-US) regulations basics on advertising and promotion for prescription products
Global Regulatory Affairs
07/2010
-
12/2014
Los Angeles, CA
- Provide through dynamic resourcing appropriate support (Subject Matter Experts) to the Innovation projects & team when assigned by manager
- Provide expertise and advice in obtaining product registrations and approvals in the Europe/EU Region, EEMEA, Latin America and AP
- Seek out opportunity by uncovering client business pains and mapping those business pains to Global Regulatory Affairs’ service solutions
- Works with management to identify target customers, markets and services that matches the company’s capabilities
- Provide support standardized and creative proposals in response to customers’ expressed needs. Follow up on proposals to customers. Maintain customer, proposal and contract database/tracking systems
- Develop relationships with both Quintiles’ traditional customer base and non-traditional/new customers and markets
- Identify and provide strategic information to support Business Development’s annual plans
- Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product
- Responsible for the GRA QMS, including implementation of QMS strategy and tactics
Summer Intern Global Regulatory Affairs Development Oncology
02/2007
-
03/2010
Dallas, TX
- Understand of the basics in pharmaceutical promotion development and review process
- Excellent English verbal and written communication skills, Ideally speaks and writes in Japanese
- Responsible for the creation, development, management and performance of the defined IT service organization
- Identify construction sourcing options as part of the project planning process
- Accountable for implementation of the sourcing strategy directives specific to the IT service
- Participate in relevant roadmapping and business case development activities to provide input on new projects (e.g. for new capabilities, lifecycle refresh, enhancements)
- Four (4) years of broad pharmaceutical industry experience, including 2 years’ experience of new drug regulated product strategy and submissions
- Work in partnership with the local regulatory teams to identify and be aware of key requirements and that they are taken into account to deliver a ‘right first time’ approach to new product development
Education
Utah State University Eastern - Price Campus
2002 - 2006
Bachelor's Degree in Science
Professional Skills
- Influencing skills without authority, advanced skills in guiding and advising
- Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines
- Effectively manage highly experienced consultants while nurturing and mentoring those less experienced
- Fluent in English and French, with excellent writing skills
- Demonstrate effective communication and influencing skills internally and externally
- Demonstrate effective cross functional and cross cultural skills including influence at external industry meetings
- Demonstrated project management skills including simultaneous management of multiple projects
How to write Global Regulatory Affairs Resume
Global Regulatory Affairs role is responsible for negotiation, influencing, research, interpersonal, english, leadership, manufacturing, finance, training, integration.
To write great resume for global regulatory affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Global Regulatory Affairs Resume
The section contact information is important in your global regulatory affairs resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Global Regulatory Affairs Resume
The section work experience is an essential part of your global regulatory affairs resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous global regulatory affairs responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular global regulatory affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Global Regulatory Affairs resume experience can include:
- Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion
- Demonstrated ability breaking down silos and rebuilding team across an organization
- Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives
- Experience preparing and coordinating the production of all regulatory documentations
- Strong understanding of related fields (manufacturing, analytical, quality assurance, and R&D)
- Prioritize task execution based on business needs
Education on a Global Regulatory Affairs Resume
Make sure to make education a priority on your global regulatory affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your global regulatory affairs experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Global Regulatory Affairs Resume
When listing skills on your global regulatory affairs resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical global regulatory affairs skills:
- Outstanding interpersonal and communication/presentation skills and strong influencing and negotiation skills
- Maintain and fully utilize broad external network to enhance business opportunities and grow market share; strong negotiation skills
- Contribute to development and evaluation of regulatory strategies for projects Excellent written and spoken communication skills in English
- Strong written and verbal communication skills in multicultural settings and ability to communicate in a succinct, logical manner
- Lead regulatory strategy, oversight and guidance and effectively leading cross functional teams
- Interact effectively with the FDA and other foreign regulatory bodies
List of Typical Experience For a Global Regulatory Affairs Resume
1
Experience For Director, Global Regulatory Affairs Resume
- Ensuring appropriate interaction with regional commercial teams in local region
- Ensuring compliance with regional requirements at all stages of product life from C2MD
- Responsible for supporting and coordinating GRA internal Policy/SOP/WI creation, review, approval, version control and ensuring consistency across
- Self-starter, capable of working alone and with cross functional teams
- Manage the regulatory submission including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
- Regular review of global procedural documents status and analysis of status reports
- Ensure continuous compliance with QMS procedural documents
- Represent GRA in global projects associated with QMS
- Tracking and ensuring timely completion of actionable items arising from bank examinations (e.g., MRA’s, Violations of Law, Recommended Actions, etc.) and IAG actionable findings
2
Experience For Associate Director, Global Regulatory Affairs Resume
- Business ownership of Otsuka’s GRA systems (e.g., submission controlled documents, publishing, and labeling, RIM) that serve as the solutions to meet GRA objectives
- Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.). Provide regulatory input for one (or more, in agreement with his/her manager) specific sections of certain/all development stages of the project/product within a given product portfolio.
- Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset primarily for the technical regulatory sections
- For cross-product sections or stand-alone documents work with the function to ensure content is aligned with targeted overall profile of the product
- Drive the interpretation of the global regulatory requirements for drug devices and combination products for both new product development for initial registration and maintenance of the registration of established products
- Ensure close collaborate with MRL device development to align on and incorporate regulatory requirements into development strategy for devices and device constituent of combination products to ensure successful product registrations
- Lead the communication of the emerging regulatory landscape and drive cross functional implementation of existing and new requirements across the affected GRACS functional areas for devices and combination products.. While enabling close collaboration between the device SME network within GRACs functions
3
Experience For Manager, Global Regulatory Affairs Resume
- Support the development of best practice guidance for regulatory deliverables for drug device and combination products to support the therapeutically aligned development teams
- Hire staff; ensure training; establish ongoing responsibilities and annual objectives; monitor performance and provide ongoing feedback; conduct routine individual and group staff meetings; and perform year-end activities consistent with Merck processes
- Collaborate cross-functionally with manufacturing, quality, technical support, R&D, and marketing; direct the CMC team efforts to ensure all important CMC submission milestones are met; support the CMC team members to work effectively with other functions to develop robust regulatory strategies and high quality regulatory submissions
- Critically review key CMC submissions
- Maintain and foster current in depth knowledge and experience applying the EMA, FDA, VICH, and other country specific CMC/Quality related guidelines to pre- and post-approval CMC submissions
- Facilitate and participate in meetings and/or inspections with the regulatory authorities on behalf of the company; in particular, act as the primary liaison with FDA-CVM on regulatory CMC related topics
- Identify and communicate potential regulatory issues to management, as needed
- Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations
- Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.). Responsible for one or more specific sections (clinical/labelling and/or technical/NC and/or procedural)
4
Experience For Assoc Dir Global Regulatory Affairs Operations Resume
- Provide regulatory input for one or more specific sections of certain/all development stages of the project/product within a given product portfolio
- Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset, for one or more sections (clinical/labelling and/or technical/NC and/or procedural)
- Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for all parts of RA aspects of a given project top line and in depth on clinical/labelling or technical/NC or procedural aspects
- Participate to project/product-related discussions and provides strategic, scientific and RA input, for all parts of RA aspects of given project topline and in depth on clinical/labelling or technical or procedural aspects
- Provide input into the asset specific regulatory strategy on a global scale
- Provide support to the GRL via critical review of one or more specific sections (clinical/labelling and/or technical/NC and/or procedural) of regulatory documents, GRPs and KMSs
- Provide input into the Global Regulatory Plan (GRP) for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections
5
Experience For Senior Sales Rep, Global Regulatory Affairs Resume
- Coordinate (for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling and/or technical/NC and/or procedural) and ensure that those documents meet regulatory requirements
- Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/NC, clinical/labelling and use of appropriate regulatory procedures to secure the optimum submission strategy; contributes for clinical/labelling and/or technical/NC and/or procedural and accountable for one of the RA aspects
- Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and technical/NC and procedural and accountable for one or several of the RA aspects
- Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s)
- In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL
- Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities
6
Experience For Manager Global Regulatory Affairs Resume
- Ensure planning and proper organisation of activities (for one or more of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones
- Provide input/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations
- Determine from a strategic and scientific perspective the content of relevant technical sections of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations.) and ensure that these documents meet high scientific standards and regulatory requirements
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities for technical or procedural sections, and ensure that those documents meet regulatory requirements
- Provide leadership ensuring that compliant regulatory strategies are developed in alignment with business objectives and implemented efficiently within timelines
7
Experience For Senior Manager, Global Regulatory Affairs Resume
- Oversight of Adverse Event Reporting process (e.g., MDR, Vigilance, MDPR, etc) to ensure that reports are prepared per procedure and guidelines and submitted within mandated time-lines
- Eight to ten years’ experience in Regulatory Affairs, four or more in medical device
- Life Cycle Management: Leading the planning, execution and assessment of product life cycle management activities and strategies
- Lead the preparation and execution of Field Action activities
- Help maintain an information network for monitoring domestic and international regulatory developments, followed by appropriate preventive communication and training within Halyard Health, Inc
- Contribute to and participate in the review of process/product changes, labeling, claims, complaints, etc., to determine the need for any regulatory activities and to ensure compliance to FDA and international requirements
- Provide regulatory support for new/modifications to product design/ project teams
- Support and participate in audits performed by internal and external representatives (e.g., FDA, Notified Body, etc.)
8
Experience For Senior Manager Global Regulatory Affairs Resume
- Lead the implementation of regulatory initiative throughout Halyard – and its facilities, includes import-export support
- Follow-up, track and assemble regulatory commitments to regulatory Agencies as required
- Demonstrated success in the preparation and acceptance of both domestic and international medical device submissions for obtaining successful marketing authorizations
- Travel, at times 10-20%, some international
- Regulatory Submissions (IND/NDA): Monitoring regulatory submission activities and reviewing regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Partnering with project teams to assess regulatory support needs and aligns resources (i.e., sub teams) to provide regulatory support
- Interfacing with Authorities: Acting as the point of contact with regulatory authorities for assigned product(s). Leads calls or meetings with regulatory authorities
- Regulatory Strategy Development: Contributing to the development of global regulatory strategies across programs for own functional area and region. Identifies, monitors and resolves regulatory issues and reports progress to management
- Compliance: Ensuring compliance with all applicable laws / regulations of each country in which we do business. Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians. Reports legal, compliance and ethical violations in a timely manner
9
Experience For R&d-global Regulatory Affairs RA Specialist Resume
- Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, usinginnovative solutions where appropriate
- Validate regulatory success paths for the Remediation project, ensuring appropriate and relevant legislative and technical elements are identified and incorporated utilising regulatory intelligence and experience
- Use regulatory expertise to assess the status of our products, identifying and communicating regulatory status, required changes, related risks and threats; feeding into action plans to manage them efficiently
- Be an active partner in development of associated processes and procedures for the Remediation Program. Is the go to person for everything regulatory within the PIR (Product Integrity Review) Hygiene Home programme
- Experience of managing a team/resources to ensure all agreed activities are delivered in full and on time
10
Experience For Manager, Global Regulatory Affairs Team Resume
- Knowledge of the regulatory environment and how it impacts product compliance with a broad understanding on what post approval maintenance entails. A good understanding of Chemical Legislations and Biocides/Disinfectants is desired
- Previous experience in remediating and/or maintaining registration or regulatory information is desirable
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries and to support of products on the market
- Consistently deliver to time, cost and quality standards in a fast-paced environment
- Provide input to/manage regulatory activities in order to obtain Marketing Authorizations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations
- Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (e.g. Global Regulatory Plan, KMS, etc.). Responsible for one specific section (clinical/labelling or technical/NC or procedural)
List of Typical Skills For a Global Regulatory Affairs Resume
1
Skills For Director, Global Regulatory Affairs Resume
- Excellent interpersonal, communication and negotiation skills are required
- Excellent interpersonal skills to interface with all levels of company structure as well as represent company to outside agencies
- Communicate effectively with external agencies and build upon Cardinal’s reputation for integrity and ethical behavior
- Analytically assimilate regulatory information and updates and effectively convey these principals to appropriate departments
- Influence and lead department members and peers as well as work effectively as a team player
- Experience in the pharmaceutical industry; 10 years of relevant experience within Regulatory Affairs
- Manager, Global Regulatory Affairs: 4+ years significant experience in regulatory affairs, or appropriate relevant experience
2
Skills For Associate Director, Global Regulatory Affairs Resume
- Ignificant experience in regulatory affairs, or appropriate relevant experience
- Biologic experience or experience in the CMV disease areas is desirable
- Impeccable ethics and proven ability to demonstrate Amicus values
- Strong customer focus and flexibility are strong assets
- Senior Global Regulatory Manager: 6+ years significant experience in regulatory affairs, or appropriate relevant experience
- Strong knowledge of global drug regulatory requirements including clinical, non-clinical and safety reporting (PADER, PSUR, Safety Labeling)
- Strong focus on broad spectrum of Cardinal Health sales opportunities including new business directions
- Previous experience in the development of medicinal products and obtaining licenses in different geographical areas
- Experience in successfully leading teams and the ability to broadly represent GRA functions on project teams
3
Skills For Manager, Global Regulatory Affairs Resume
- Previous experience in regulatory affairs within industry is required to ensure appropriate level of understanding of the RA activities and impact
- Experience critically reviewing detailed scientific information to ensure information is presented clearly and conclusions are supported by data
- Able to deal with changing priorities or unexpected events
- Previous experience working in a fast paced environment on multiple product line
- Proven ability to manage and grow productive teams
- Manager, Global Regulatory Affairs: 4+ years significant experience in regulatory affairs
4
Skills For Assoc Dir Global Regulatory Affairs Operations Resume
- Knowledge and applicable experience in global regulatory requirements
- Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics is required
- Experience leading regional development, submission and approval activities in local region(s)
- Experience of all phases of the drug development process in regulatory affairs
- Broad pharmaceutical industry experience in new drug regulated product strategy and submissions
- Pharmaceutical experience with at least 5 years in CMC in a globally regulated environment
5
Skills For Senior Sales Rep, Global Regulatory Affairs Resume
- Excellent working knowledge of regulatory requirements to distribute drugs in the US; FDA, DEA, and state regulations and statutes
- Experience with the clinical trial phase of development, e.g. IND / CTA / eCTD requirements
- Understanding of the scientific and medical principles applicable to the therapeutic area and specific products
- Understanding of how supply chain decisions impact registrations in AP
- Living our leadership behaviors is a basic expectation for all employees
- Ensuring close collaborate with MMD involved in drug/device activities to support regulatory compliance and successful product registrations
6
Skills For Manager Global Regulatory Affairs Resume
- Functional understanding of Change Control processes supporting manufacturing operations and CMC dossier management
- Able to input into the Company’s regulatory positioning, and write /critically review key documents targeting internal or external key audiences
- Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review and oversight
- Able to input into the Company's regulatory positioning, and write /critically review key documents targeting internal or external key audiences
- Work closely with regulatory policy to impact evolving requirements by actively engaging externally in the drug/device area
- Efficient ‘in house’ GSK influencing to
- Negotiation with data generating unit Management to ensure that data for files are generated on time for regulatory submissions and in accordance with RA needs
- Interprets and applies applicable laws, regulations and guidelines governing devices and drugs, to meet business objectives
7
Skills For Senior Manager, Global Regulatory Affairs Resume
- Assist in clinical studies required for regulatory approvals, including clinical study design, data analysis, and data reduction
- Obtain and disseminate information regarding current activities, trends and changes in the regulatory environment
- Host FDA/third party regulatory audits and ensure follow up on findings/observations issued including CAPAs, as needed
- Strategic mindset and approach coupled with a hands-on operating style
- Identify emerging technologies and instrumentation and make appropriate recommendations for business application
- Arbitrate conflicts between departments regarding quality and regulatory issues
- Exposure to global projects, working with different cultures and with travel opportunities
- Thorough understanding of regulations of ICH, FDA and EMA
- Awareness of pricing and reimbursement issues in AP
8
Skills For Senior Manager Global Regulatory Affairs Resume
- Develop and implement global regulatory strategies to meet Health Authority expectations in target regions according to the RSD for the product concerned
- Ensure an understanding of the external regulatory competitive environment globally in order to adapt product regulatory strategy accordingly
- Sound knowledge and understanding of company products as they relate to medical device and drug law and international medical device requirements
- Provide motivational leadership to help the global regulatory organization understand the company’s strategy and future
- None Required. Regulatory Affairs Certification (RAC) desirable
- PMP, APR, Change Management (IMA certification) (recommended)
- Influence decisions of authorities by adequate defense of the Company’s position on technical scientific matters
- Participate and/or defend regulatory position for transversal technical matters in Company Governance/Advisory Bodies (e.g. TDB, Primary Biotech, Secondary Biotech)
9
Skills For R&d-global Regulatory Affairs RA Specialist Resume
- Interacts with health authorities on submission and review of device products and post-marketing device projects; directs the preparation of worldwide device submissions to health authorities and ensures the quality and content of submissions
- Advises the Project Teams on regulatory issues concerning company’s devices products
- Partners with internal departments and ensures development plans meet regulatory requirements and guidelines
- Monitors, reviews, and analyzes development of new requirements and regulations and provides input on impact for products/projects
- Develops policies and procedures to ensure regulatory compliance; provides direction and mentoring to regulatory staff; manages regulatory consultants hired and assigned to operational roles; attends congress and professional meetings, and acts as a company spokesperson, as required
10
Skills For Manager, Global Regulatory Affairs Team Resume
- Oversee the conduct and reporting of M&A, and licensing due diligence activities pertaining to global regulatory affairs
- Promote and integrate industry best practices that fit well with the Sunovion’s operating culture
- Promote a highly interconnected Global Regulatory Affairs operating culture
- Facilitate the compliance to global SOPs and work practices governing all phases of the regulatory process
- Establish key business metrics (i.e., Key Performance Indicators) with market reference points to gauge department performance, productivity and efficiency
- Serve as delegate and/or senior expert on all global regulatory matters with key external stakeholders (e.g. PhRMA), internal steering/review committees, business partners, and government entities on a global basis
- Promote awareness of regulatory requirements cross functionally through comprehensive internal education initiatives
- Ensure global compliance with all relevant internal and external policies and regulations applicable to drug development and regulatory approval
- Establish resource plans to ensure that Global Regulatory Affairs strategy and operational plans are appropriately resourced to support the Company’s business goals
List of Typical Responsibilities For a Global Regulatory Affairs Resume
1
Responsibilities For Director, Global Regulatory Affairs Resume
- Provide in-depth regulatory input for one (or more, in agreement with his/her manager) specific sections of certain/all development stages of the project/product within a given product portfolio
- Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset for a technical section
- Support the Global Regulatory Lead/Technical Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies
- In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL/ Technical Lead, within the remits of his/her expertise area
- Prior experience maintaining INDs, CTAs, BLA, NDAs
- Demonstrated Leadership Experience
- Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
2
Responsibilities For Associate Director, Global Regulatory Affairs Resume
- Managing/leading strategic interactions with Health Authorities
- Ensuring the understanding of the external regulatory competitive environment globally in order to adapt product regulatory strategy accordingly
- Serving as the Global Regulatory Lead (GRL) representative on the Global Program/project team
- Leading development of regulatory strategy, ensure global consistency, implementation and communication of strategy for the assigned product(s)
- Being accountable for regulatory strategic and operations matters within the Program / Project team for assigned projects
- Being an expert in Clinical Trial Regulations
3
Responsibilities For Manager, Global Regulatory Affairs Resume
- Providing support and regulatory expertise to Sanofi key stakeholders
- Contributing to set up of new processes to implement new regulations ( e.g. New Clinical Trial Regulation in Europe, EU Clinical Data Disclosure)
- Follow-up sending, submission, approval of CTA package, identifying any issues and proposing resolution
- Participate in GRA Quality Committee (GRAQC) and ensure actions resulting thereof are being implemented
- Lead the planning and implementing global regulatory filings
- Drives ongoing process improvement to deliver increasing operational efficiency in all GRA business processes
4
Responsibilities For Assoc Dir Global Regulatory Affairs Operations Resume
- Assist in supporting Director in the development of internal monthly management reports, metrics dashboards and maintaining executive dashboard as needed
- Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.). Responsible for one specific section (clinical/labelling or t/NC or procedural)
- Provide regulatory input for one (or more, in agreement with his/her manager) specific sections of certain/all development stages of the project/product within a given product portfolio.
- Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset, for a specific section (clinical/labelling or technical/NC or procedural)
- Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for clinical/labelling or technical/CMC or procedural aspects of a given project
- Participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, for clinical/labelling or technical/NC or procedural aspects of given project
- Ensure alignment and productive collaboration with Hib manufacturing sites by possibly travel
- Provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or technical/NC or procedural aspects
5
Responsibilities For Senior Sales Rep, Global Regulatory Affairs Resume
- Provide support to the GRL via critical review of the clinical/labelling or technical/NC or procedural section of regulatory documents, GRPs and KMSs
- Provide in-depth input on clinical/labelling or technical/NC or procedural aspects/sections of the Global Regulatory Plan (GRP)
- Coordinate (for one specific clinical/labelling or technical/NC or procedural part) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling or technical/NC or procedural sections) and ensure that those documents meet regulatory requirements
- Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/NC or clinical/labelling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or technical/NC and/or procedural aspects
- Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and/or technical/NC and/or procedural aspects
- In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her expertise area (clinical/labelling and/or technical/NC and/or procedural)
6
Responsibilities For Manager Global Regulatory Affairs Resume
- Ensure planning and proper organisation of activities (for one of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones
- Demonstrate excellent communication and influencing skills internally and externally
- Desirable to have previous experience in Oncology therapeutic area
- Develop registration strategies to support introduction or extension of new and existing products
- Ensure regulatory considerations are evaluated and addressed during change control process
- Provide regular reporting to management on registration metrics and department activities
7
Responsibilities For Senior Manager, Global Regulatory Affairs Resume
- Provide review and approval of product labeling and promotional materials
- Responsible for cost center and financial management to annual operating plan and budget
- The job holder’s working environment is composed of managers/scientist of multiple origins
- Prepare Module 3 Marketing Authorization Application for Japan
- Prepare Module 3 Marketing Authorization Application for Brazil
- Focus on providing oversight of nonclinical and clinical aspects of drug development and associated global regulations for assigned program(s)
- Curiosity and passion for science and new manufacturing technologies
8
Responsibilities For Senior Manager Global Regulatory Affairs Resume
- Oversee the execution of strategies to ensure the timely and cost efficient of product registrations and market adoption
- Ensure all registration activities comply with applicable government and local regulations
- Collaborate cross-functionally to ensure regulatory requirements are incorporated into project plans
- Develop policies, programs and procedures for regulatory affairs
- Primary interface with FDA on submissions and meetings
- Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for clinical/labelling and procedural aspects of a given project
- Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for technical/CMC aspects of a given project
- Develop KPIs for key compliance activities and analyze quality compliance metrics
- Regulatory files are prepared for and submitted world-wide (US, EU, Japan, Intl), hence requiring flexibility and adaptations to each country culture, regulations, mindset and constraints
9
Responsibilities For R&d-global Regulatory Affairs RA Specialist Resume
- Pharmaceutical industry experience, with at least 3 years of global CMC regulatory experience
- Develop and prepare successful regulatory strategies and dossiers
- In-depth knowledge of global pharmaceutical legislation
- Provide regulatory input for one (or more, in agreement with his/her manager) specific sections of certain/all development stages of the project/product within a given product portfolio
- Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT, etc.) and possibly project teams (PTs), for clinical/labelling or technical/CMC or procedural aspects of a given project
- Provide input to Vaccines Development Plans in order to optimize the label and secure proper alignment of technical/NC or clinical/labelling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or technical/NC and/or procedural aspects
- In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL within the remits of his/her expertise area (clinical/labelling and/or technical/NC and/or procedural)
- Ensure planning and proper organization of activities (for one of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones
- Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg. Global Regulatory Plan, KMS, etc.). Responsible for one specific section (clinical/labeling or t/NC or procedural)
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Responsibilities For Manager, Global Regulatory Affairs Team Resume
- Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset, for a specific section (clinical/labeling or technical/NC or procedural)
- Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for clinical/labeling or technical/CMC or procedural aspects of a given project
- Participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, for clinical/labeling or technical/NC or procedural aspects of given project
- Prior experience with Health Agency Interactions
- Prior experience with the development of neurology and /or immunology products is desired
- Biologic medicine experience or experience in CVM disease areas is desirable
- Experience in preparation and management of comprehensive drug development programs (IND/CTA submissions for FIM to phase 3 and registration phase)
- Experience with development and preparation of successful regulatory strategies and ability to write and defend such strategies
- Experience with regulatory project development activities and MAA/NDA management
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