Associate Director, Regulatory Affairs Resume Sample
Arnulfo Thompson
88312 Auer Hill,
Detroit,
MI
+1 (555) 326 4496
Work Experience
Associate Director, Regulatory Affairs
03/2016
-
PRESENT
Philadelphia, PA
- Works to assure products remain in compliance
- Build Regeneron’s regulatory profile in the EU, and serve as a resource for EU knowledge for the global regulatory and development teams
- Build the representation of Regeneron's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required
- Assist Development teams and Regulatory senior management in developing Regulatory strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular, the application of innovative regulatory pathways to our development products
- Provide leadership on MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling
- Support activity with Business Partners to ensure the EU regulatory strategy meets Regeneron’s business objective
- Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate)
- Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required
Associate Director Regulatory Affairs
03/2009
-
11/2015
Philadelphia, PA
- Proven track record of supporting EU Clinical Trial Applications through approval and study start up
- Negotiate and concisely express clear positions to stakeholders at all levels
- Experience of directly working with national regulatory agencies and leading agency meetings face to face
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is an advantage
- Experience of bringing a product through EU approval is a distinct advantage
- Alternatively, comparable experiences as those above through work at a regulatory agency
- Conducting resource and capacity analysis for
Associate Director Regulatory Affairs Strategy
02/2003
-
10/2008
Phoenix, AZ
- Demonstrated strong writing and communication skills
- Function well as a member of the team and build relationships between RA and other areas of the organization
- Able to identify and assess business risks for a given Regulatory strategy
- Oversee day-to-day performance of employees, organize the function of a group, and provide leadership as necessary
- Connect to cultivate external relationships with affiliates, and interval cross function partners
- Shape by executing strategies developed by COE
- Lead team by example and mentoring
- Deliver results for timely submissions regulatory documentation with global strategy balance
Education
Chatham University
1997 - 2002
Bachelor's Degree in Science
Professional Skills
- Experience in working/leading project teams; demonstrated project management skills is required
- Inspirational leader with excellent communication skills and a proven ability to mentor, manage and direct staff for optimal results
- Inter-dependant partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment
- Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results
- Strategic thinking ability and strong problem solving skills
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously
- Positive attitude & excellent communication skills
How to write Associate Director, Regulatory Affairs Resume
Associate Director, Regulatory Affairs role is responsible for influence, leadership, interpersonal, regulatory, negotiation, software, manufacturing, database, technical, organizational.
To write great resume for associate director, regulatory affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate Director, Regulatory Affairs Resume
The section contact information is important in your associate director, 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 Associate Director, Regulatory Affairs Resume
The section work experience is an essential part of your associate director, 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 associate director, 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 associate director, regulatory affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate Director, Regulatory Affairs resume experience can include:
- Excellent written, verbal and presentation skills including experience presetting at meetings with Regulatory Authorities
- Excellent verbal, written, negotiation, influence and interpersonal communication skills
- Demonstrated ability to effectively formulate and drive change
- Negotiating and conflict handling skills
- Working knowledge of regulatory requirements for various drug dosage forms including solids, semi-solids, solutions is required
- Demonstrating leadership skills with a sphere of influence externally, cross-functionally and within the RA function and in the affiliate
Education on an Associate Director, Regulatory Affairs Resume
Make sure to make education a priority on your associate director, 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 associate director, 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 Associate Director, Regulatory Affairs Resume
When listing skills on your associate director, 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 associate director, regulatory affairs skills:
- Strong business acumen – business and financial judgement, problem solving skills and ability to distil large volumes of data/information
- Demonstrated ability to effectively perform in a team environment and help a team achieve its goals
- Excellent people, communication and leadership skills for interaction with cross-departmental teams
- Excellent people, communication and leadership skills
- Pharmaceutical industry experience, including 3-5 years in regulatory affairs. Global experience desired
- Demonstrated experience in preparing FDA submissions
List of Typical Experience For an Associate Director, Regulatory Affairs Resume
1
Experience For Associate Director Regulatory Affairs Resume
- Excellent verbal, written, organization skills and interpersonal communication skills
- Excellent decision making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated
- Work in a multi-disciplinary team effectively
- Successful experience in all components of regulatory submissions including chemistry, manufacturing and control, non-clinical, and clinical documentation
- Creative approach to problem solving with a demonstrated track record of being results driven
- Considerable experience and increasing documented success in a biopharmaceutical field specifically working on biotechnology based products
- ≥10 years of experience working in a regulated environment
- Demonstrated self-starter and highly motivated, energetic and enthusiastic
2
Experience For Associate Director, Regulatory Affairs CMC Resume
- Experience in assessing post-marketing changes
- Experience working directly in Regulatory Affairs – CMC
- Runs an effective and efficient regulatory sub-team, a matrix team that includes all functions needed to execute the accountabilities of the member
- Strong knowledge of global Device regulatory requirements
- Performing regulatory administrative activities as needed in support of the oncology TA
- Provides operational support for Quality, Manufacturing and Testing activities as it relates to Regulatory and Compliance
- Function as primary liaison with health authorities, including providing complete and timely responses to health authority requests for information
- Monitors global regulatory developments affecting BD’s POC programs and products and communicates emerging opportunities and concerns to stakeholders
3
Experience For Associate Director Regulatory Affairs Strategy Resume
- Lead all Regulatory communications with FDA and international competent authorities including authoring Pre-IDE, Risk Assessment, IDE and PMA submissions
- Develop and implement supporting training material as needed
- Oversight of training curricula and training plans
- Assist in review of international product labeling and marketing materials
- Advanced understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
- Establish and maintain training documentation system
- Develop and maintain metrics for EPD RA training compliance
- Secures global resource deployment (e.g., Med Writing, Safety, PhD, Supply Chain) to ensure implementation of regional strategies
4
Experience For Associate Director Regulatory Affairs CMC Resume
- Analyses regional & HA feedback to foster adaptive learning
- As a member of the Regional Strategic Implementation Group participates in setting of operational direction
- Coordinate and manage dissemination of CMC changes to marketing partners and manage health authorities’ review of such changes
- Facilitate timely regulatory approvals of new drugs and life cycle activities by insuring the quality and appropriateness of submissions
- Review and approve labeling for the company’s products
- Support product labeling efforts from inception to final negotiation
5
Experience For Associate Director, Regulatory Affairs, CMC Resume
- Knowledge of US regulatory requirements and opportunities for expediting development programs for serious conditions
- Familiarity with labeling and CMC concepts is desirable
- Facilitate timely regulatory approvals of new drugs and life-cycle activities by ensuring the quality and appropriateness of submissions
- Manage interactions with other functions (e.g., Quality, Compliance) during Regulatory Authority inspections
- Determine the people, funding, materials and support to meet project and program goals and timelines
- Ensure training plans are in alignment with quality system document requirements
- Support audits and inspections involving EPD RA
- Manage and maintain oversight of EPD RA ROC activities, internal cross-functional support, and third party record sharing arrangements
- Ensure quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOPs
6
Experience For Associate / Director, Regulatory Affairs Resume
- Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
- Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements
- Provide leadership to maintain compliance with constantly changing domestic and international regulations as well as management of state and/or local Licenses
- Oversee planning, preparation, submission and maintenance of INDs and international equivalents
- Provide strategic insight to the core and clinical development teams regarding product development
- Proactively interact with USG and FDA regulatory experts to expedite approval of pending submissions
- Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials, as needed
7
Experience For Associate Director, Regulatory Affairs Resume
- Provide regulatory training to cross-functional groups
- Oversees Medical Device Reporting process and procedures, FDA Inspections, 483 Responses, and other communication topics, as needed
- Perform various submissions, including IND, NDA, and other routine submission work
- Provides guidance to project team members regarding regulatory issues
- Establish and maintain sound working relationships with collaborators and customers
- Creative approach to problem solving; ability to deal with ambiguity, define a clear path forward and be able to articulate and argue for the strategy
- Monitor regulatory intelligence and identify and communicate changes impacting APOC
- Decision Making: Make important decisions that impact the therapeutic areas and ensure appropriate communication
- Play an active role in industry organizations building recognition as a thought leader, as required locally if appropriate
8
Experience For Associate Director Regulatory Affairs Resume
- Negotiate with regulatory authorities during the development and review process to ensure submission approval
- Manage processes and personnel involved with maintaining annual licenses, registrations, listings and patent information
- Review and approve labeling to ensure compliance
- Responsible for ensuring that Celgene fulfils Health Authority commitments
- Ensure where required country-specific submission packages are made available to the local operating companies
9
Experience For Associate Director, Regulatory Affairs CMC Resume
- Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labelling
- Regulatory reviewer in due diligence for licensing opportunities, development and /or marketed product opportunities
- Establish and maintain the EPD (Established Pharmaceutical Division) RA (Regulatory Affairs) Quality System
- Audit and Inspection Administrator and other support
- EPD RA Management Review
- EPD RA Records Operations Center (ROC) Record Archive Management and oversight
- Justifies position (legal, ethical, or scientific) when there are differences of opinion in connection with a request from regulatory authorities
- Regularly monitors commitments/obligations in response to regulatory requirements or requests
10
Experience For Associate Director Regulatory Affairs Strategy Resume
- Performs support functions for Quality Assurance
- Manages project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget. Leads and participates in project meetings
- Ensures identification of out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modification
- Collaborates with business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD
- Experience with clinical development programs, INDs, NDAs/sNDAs/ANDAs, monograph products and knowledge of the Rx-to-OTC switch process are required
- Contributes to development and implementation of global/regional function/plans
- Ensures compliance with relevant organizational and department SOPs and WPDs
- The company operates in a highly regulated business environment. Many of the products in the OTC portfolio are approved under a New Drug Application (NDA) or Marketing Authorization Application (MAA) and some contain active ingredients also marketed as prescription drugs
- Tactical and strategic regulatory and business knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products
List of Typical Skills For an Associate Director, Regulatory Affairs Resume
1
Skills For Associate Director Regulatory Affairs Resume
- Strong interpersonal and organizational and problem-solving skills
- Strong negotiation skills as it relates to regulatory bodies worldwide
- Demonstrated evidence of writing of regulatory documents (e.g., Module 1, Module 2, briefing packages, orphan drug designation applications, pediatric plans)
- Critical thinking and decision-making skills is required
- Strong familiarity and two (2) years of hands-on experience working with device regulations
- Proven experience of managing risk, risk profiles and the alignment of strategy based on Risk
- Demonstrated experience in working in a cross-functional and cross divisional environment
- Strong experience in manufacturing change control and global registration data management for the execution of CMC strategy and submissions
- Proven track record of effective collaboration with regulatory agencies, including the FDA
2
Skills For Associate Director, Regulatory Affairs CMC Resume
- Professional work experience required to include at min. 6 years of pharmaceutical drug regulatory affairs experience
- Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs
- Detail-focused with ability to multitask effectively and work efficiently within a strict timeline-driven environment
- Effective at energizing others, establishing clear goals, mentoring and coaching team members
- At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields
3
Skills For Associate Director Regulatory Affairs Strategy Resume
- Experience leading, developing and implementing complex CMC regulatory strategy
- Demonstrated success on independently leading/delivering on project objectives
- Experience manipulating and mining large data sets, especially to support the analysis of complex operations
- Experience driving and oversighting transformational change is desirable
- Experience in managing major regulatory filing(s) such as IND or BLA
- Creative approach to problem solving; with a demonstrated track record of being results driven
4
Skills For Associate Director Regulatory Affairs CMC Resume
- Proven understanding of current state-of-the-art manufacturing, controls, and analytical requirements associated with biologics development and approval
- Experience managing complex CMC submissions and interacting with global regulatory authorities
- Experience performing various submissions, including IND, NDA, etc
- Manage budgets and resources, including skilled professionals, and achieve activity goals
- Significant experience of leading multiple projects through Centralized Regulatory Procedures
- Significant experience of contributing to Ph HI development plans
- Min 5 years of direct people leading experience
- Experience directly working with the FDA to through the submission process and to resolve on market issues
- Regulatory affair experience including 5 years in managerial role
5
Skills For Associate Director, Regulatory Affairs, CMC Resume
- Substantial experience multitasking in a deadline controlled and highly regulated environment
- Experience managing internal staff and/or external consultants
- Demonstrated excellence in developing global regulatory affairs strategy
- Regulatory experience with a focus on supporting products through clinical development
- Experience working on large-scale, global initiatives
- A thorough working experience in a regulatory affairs department with knowledge of FDA and or USDA divisions, personnel, and procedures
- Experience working with regulators or government agencies
6
Skills For Associate / Director, Regulatory Affairs Resume
- Demonstrated ability to make risk based decisions (value creation through managing risk)
- Evidence of successful submissions to FDA (e.g., INDs, briefing packages)
- Strong aptitude for understanding regulatory systems and processes
- Demonstrated situational leadership and creative problem solving within organizations and teams
- Previous experience in leading cross-functional teams
- Strong technical/science-based background (QA, Manufacturing and/or Lab) is required
- Experience interacting with health authorities
- Able to manage conflicting priorities and adhere to tight timelines
- Demonstrated ability to drive a collaborative, customer-focused, learning culture is highly desired
7
Skills For Associate Director, Regulatory Affairs Resume
- Create and manage strong network with key stakeholders such as marketing, legal, and other scientific personnel that facilitate collaboration
- Regulatory Knowledge: Demonstrates expert knowledge of US regulatory guidances. Serves as RA CMC representative supporting company initiatives
- Experience in directly managing multi-level staff, provide direction to work groups and cross functional teams
- Strong strategic regulatory expertise across phases of drug development
- Strong knowledge of global health authority regulations and practices
- Direct experience in biologics
- Experienced in continuous improvement projects, project management, and product development processes
8
Skills For Associate Director Regulatory Affairs Resume
- Experience on a team working with fast-paced, breakthrough drug development
- Strong working knowledge of U.S. and EU regulatory requirements for biologics and small molecules, with preference for antibody drug conjugates
- Provide guidance on the content and suitability of regulatory documents for submission such as comparability, validation, and development reports
- Conducting all activities with an unwavering focus on regulatory conformance
- Implementing strategy to develop Agency background packages and documents associated with Regulatory submissions for marketing applications
- Communicating with Agencies and attending Agency meetings as needed to assist the global liaison
- Motivating financial remuneration & Many employee benefits
- Contributing to establish organizational and process efficiencies for management of CMC Health Registration data and change control coordination (GCM, ORION)
- Acting as a change agent for the team in the establishment of new capabilities
9
Skills For Associate Director, Regulatory Affairs CMC Resume
- Assisting with process improvement initiatives
- Performing regulatory administrative activities as needed
- Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents
- Provides leadership, personnel development, training, coaching, and mentoring for teams and direct reports
- Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
- Supports post marketing activities including adverse event reporting and product removal/recalls
- Provide leadership, personal development, training, coaching and mentoring for staff
- In-depth knowledge of core processes of drug discovery, development, manufacturing & marketing required
- Successful track record in contributing to/managing cross-functional teams
10
Skills For Associate Director Regulatory Affairs Strategy Resume
- Knowledge and understanding of the animal health sector with a consistent analytical approach to problem-solving
- Capable of delegating tasks and facilitating the completion of assignments
- Capable of driving innovation in developing new ideas related to process improvements
- Oversee the planning and preparation of submissions to regulatory authorities, both related to IND maintenance and marketing authorization
- Lead product labeling for all new and on market products, insuring compliance with regulations
- Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages
- Oversee planning, preparation, submission of planned marketing applications
- Oversee maintenance of approved US BLA, including multiple post-marketing clinical studies
- Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes
List of Typical Responsibilities For an Associate Director, Regulatory Affairs Resume
1
Responsibilities For Associate Director Regulatory Affairs Resume
- Work independently and effectively in a multi-disciplinary team
- Experience with effective project team leadership and management oversight
- Interprets and communicates HA correspondence effectively and quickly to GRA Sr. Management, senior leadership, and project teams
- Viewed as a peer with business leaders – strong track record of establishing credibility and building trust at all levels. Sought out as a thought leader
- Strategic planning experience in Regulatory Affairs for Medical Devices
- Experience working with novel US Government-related submissions, where the intended use population is limited or non-accessible
2
Responsibilities For Associate Director, Regulatory Affairs CMC Resume
- An understanding of the current Regulatory environment and demonstrated ability to perform within it
- Direct experience and working knowledge of a range of US regulatory submission types
- Advanced Therapy Medicinal Product and Orphan drug experience is preferable
- Strong understanding of Medical Device regulations / standards and Quality principles is required
- Extensive hands on experience in activities such as product approval applications, crisis management such as product recalls, FDA inspections is required
- Marketing Authorisation (MA) applications
3
Responsibilities For Associate Director Regulatory Affairs Strategy Resume
- Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labeling
- Improve existing processes, identifying opportunities for improvement, generating ideas and implementing solutions
- Positive attitude, proactive, ability to work with minimal supervision and comfortable working and communicating independently
- Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams
- Expert understanding of CTD modules; non-clinical, CMC, Clinical
- Proactively manages and communicates issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed
- Able to establish close communications and working relationship with cross functional teams to meet business objectives
- Drive understanding of central and national regulatory requirements
- Managing US 510k submissions
4
Responsibilities For Associate Director Regulatory Affairs CMC Resume
- Interpret subjective and complex aspects of specific regulations and a thorough understanding of multiple sets of associated regulations
- Track record of working with multiple internal departments like Quality, Clinical Affairs, Program Management, R&D and Commercial
- Provide regulatory leadership on project teams while leading development of medical device regulatory strategy and operations
- Demand forecasting in the research and development space
- Versatile and fulfilling role in a dynamic environment
- Knowledge and understanding of the animal health sector
5
Responsibilities For Associate Director, Regulatory Affairs, CMC Resume
- Resilient – remains calm in demanding situations
- Interface with corporate PRC/regulatory affairs on advertising and promotional materials
- Oversee the implementation of an electronic system for submission of advertising/promotional materials consistent with FDA guidance and timelines
- Keep abreast of current information relating to the promotion of drugs, biologics , medical device and combination products
- Interact with regulatory operations team at external regulatory consulting firm
- Knowledge of FDA’s regulations and guidelines on advertising and promotional drug products is required
6
Responsibilities For Associate / Director, Regulatory Affairs Resume
- Identify need for new regulatory policies, processes and SOPs and approve them
- Evaluate regulatory risks of corporate policies
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
- Develop global regulatory strategies and update based upon regulatory changes
- Conduct regulatory due diligence for potential and new acquisitions and advise management
- Prepare responses to health authorities’ review letters, and requests for additional information
- Provide strategy and direction to product teams addressing the regulatory requirements for both quality submissions and for manufacturing inspection requirements for CMC controls, maintaining forecasted timelines in support of the overall programs
- Lead cross-functional teams for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD, BLA, MAA, NDA and their amendments/supplements
7
Responsibilities For Associate Director, Regulatory Affairs Resume
- Lead and manage regulatory professionals supporting the assigned program(s) in a manner that blends the organizational needs with their developmental needs
- Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed
- Extensive knowledge of FDA regulations, practices and ICH guidances
- Represents the function on designated teams, conduct business interactions with customers and regulatory authorities surrounding regulatory pathway, performance claims, supporting data, and labeling (including advertising and promotional materials) in the context of submissions or registrations, and serve as the regulatory expert on the projects
- Develops and executes aggressive weighted with realistic regulatory strategies for a range of complex regulatory affairs programs with emphasis on requirements and submissions associated with IVD systems (hardware, software, reagents, etc.)
- Develops, monitors, and reports to senior management key performance indicators. Mentors regulatory associates and develop for career advancement
- Driven leadership with an emphasis on talent development
8
Responsibilities For Associate Director Regulatory Affairs Resume
- Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators
- Familiar with Design control documents; History Files, Device History Records, QC testing, Stability reports, etc
- Computer literacy (SAP, PC, Microsoft Word/Excel/PowerPoint)
- Willingness to travel up to 20% of the time (domestic and international)
- Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures
- Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks
- Prepare company team for FDA and other health agency meetings, as required
- Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions
9
Responsibilities For Associate Director, Regulatory Affairs CMC Resume
- Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients
- Ensure receipt of timely and actionable health authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions
- Assess regulatory program risks for likelihood and impact; establish mitigation strategies
- Able to consider and account for multiple options and opinions
- Able to travel for meetings with corporate partners and regulatory authorities
- Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the global liaison in authoring of regulatory strategy documents
- Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC) as well as other functional areas (e.g. clinical research, safety assessment)
10
Responsibilities For Associate Director Regulatory Affairs Strategy Resume
- Prioritize and manage FDA product and other regulatory-related submissions adhering to timelines, liaising regularly with FDA, where appropriate
- Support maintenance (e.g., quality compliance and life cycle management) of VID programs
- Support of Global liaison in label development
- Provide strategy and direction to product teams addressing the regulatory requirements for quality submissions, clarifying manufacturing requirements for appropriate CMC controls, and maintaining forecasted timelines in support of the overall programs
- Serve as a liaison between regulatory authorities, partners and the company on CMC issues
- Maintain up-to-date knowledge and expertise of relevant FDA, ICH and other applicable guidelines and regulations
- Lead partnerships and collaborations for CMC-related submission matters for both clinical and commercial status products
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