Regulatory Assistant Resume Sample

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Pete Farrell
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Work Experience


Regulatory Reporting, Assistant VP
08/2016 - PRESENT
Detroit, MI
  • Site Initiation Visits: Assemble needed documents, schedule visits with CISO staff, IDS, and MDs, navigating guests throughout the entire schedule of activities. Complete all relevant documentation and maintain tracking logs
  • New Study Regulatory Submission: Assemble, provide order, complete signature requirements, and finalize all new study packets for submission to the IRB of record
  • Assist with updating regulatory documents for all ongoing studies
  • Maintain and update Investigator CVs, licenses, and pertinent data in CISO databases
  • Maintain and update CLIA and other agency certificates as directed
  • Maintain and update lab normals within CISO accessed databases as directed
  • Work with many different roles within and outside the USC Norris Comprehensive Cancer Center, successfully meeting internal and external needs of study related contacts
Assistant VP Regulatory Compliance Consumer Disclosure
09/2011 - 04/2016
Chicago, IL
  • Master regulatory banking concepts and regulations quickly
  • Multi-task and mange priorities effectively under tight deadlines
  • Excellent interpersonal skills when interacting with peers and other bank associates
  • Strong project management, change management, and/or process improvement skills is highly desirable
  • Prior experience in providing knowledge management support is highly desirable
  • Knowledge of banking, financial services products, and financial regulations
  • Engage with local supply chain and the regulatory team to prepare and maintain an appropriate schedule for new label production and updates to existing labels. Ensure that this plan is delivered and that any issues are raised for resolution in a timely manner
  • Create labels with the correct architecture and content, check the proofs, release the label after all appropriate approval steps are complete. Liaise with graphic agencies etc. as necessary
Regulatory Policy & Intelligence Assistant
11/2005 - 05/2011
New York, NY
  • Monitors changes to federal and state financial laws, regulations, and cases affecting the banking industry
  • Assists in analyzing the regulatory changes
  • Conducts legal research on laws, regulations and cases affecting the banking industry
  • Creates draft memoranda, legal research summaries, and analyses of regulatory changes
  • Assists in conducting business due diligence and compliance reviews
  • Maintains regulatory change records, including meeting minutes and the SharePoint site
  • Provides administrative support to the regulatory change management team
  • Prepares Microsoft Excel reports and PowerPoint presentations
  • Proficiency with research tools such as Lexis, Westlaw, the Internet as well as standard Microsoft Applications

Education


Averett University
1999 - 2004
Bachelor's Degree in Business

Professional Skills


  • Strong critical thinking and problem solving skills with proven ability to apply creative approaches to complicated questions
  • Computer skills, proficiency in MS-Office, specifically Word, Excel and Outlook. Internet research skills are highly desired
  • Good interpersonal skills, communication skills, and the ability to work with others in regulatory and other groups within the company
  • Strong organizational skills as well as conceptual, problem solving, critical thinking, and research abilities are necessary
  • Excellent English and either Danish, Swedish or Norwegian skills in both speech and writing
  • Excellent relationship management skills to build and maintain effective working relationships with colleagues in other business units and with external bodies
  • Strong PC skills, ability to use we-based applications and programs

How to write Regulatory Assistant Resume

Regulatory Assistant role is responsible for research, computer, organizational, regulatory, planning, articulate, excel, oncology, auditing, litigation.
To write great resume for regulatory assistant job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Regulatory Assistant Resume

The section contact information is important in your regulatory assistant 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
  • Email
  • Telephone number

Work Experience in Your Regulatory Assistant Resume

The section work experience is an essential part of your regulatory assistant 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 regulatory assistant responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory assistant position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Regulatory Assistant resume experience can include:

  • Effectively manage multiple projects with shifting priorities
  • Effective project management and communications skills
  • Excellent computer skills (proficient in Windows, MS Word, Excel, PowerPoint)
  • Independent decision making and analytical thinking skills
  • Validates that all products and advertisement have been through the appropriate approval processes, prior to sharing or publishing
  • Demonstrated ability to establish priorities and handle multiple tasks, showing attention to detail

Education on a Regulatory Assistant Resume

Make sure to make education a priority on your regulatory assistant resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory assistant 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 Regulatory Assistant Resume

When listing skills on your regulatory assistant 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 regulatory assistant skills:

  • Good problem solving skills and the ability to work to tight deadlines
  • Good capability to communicate effectively and to work in group
  • Strong organizational, interpersonal and communication skills; team orientation
  • Excellent communication skills and the ability to professionally coordinate and interact with co-workers and client staff required
  • Excellent organization skills and acute attention to detail
  • Independent self-starter; manages time effectively and completes tasks on-time with general supervision. Flexible and able to self-manage multiple priorities

List of Typical Experience For a Regulatory Assistant Resume

1

Experience For Regulatory Reporting, Assistant VP Resume

  • Have an interest in progressing with a career within regulatory affairs in cosmetic, pharmaceutical or consumer goods
  • Answering to medical inquiries
  • Support the regulatory team with pre-submission activities (e.g. preparing and/or checking the local documentation, burning the CDs etc.)
  • Support the regulatory team with post-submission activities (e.g. archiving, updating tracking tools)
  • Assists with ordering supplies and maintaining account records, using PeopleSoft and Excel. Monitors, orders, and distributes all department office supplies
2

Experience For Assistant VP Regulatory Compliance Consumer Disclosure Resume

  • Determine reliability of data sources by evaluating information, determining errors and notifying responsible parties
  • Build an updated Archiving system (Soft and hard format) and archive on MEAP sharing space (archiving system founded by Global Team)
  • Be excited about being in a fast-paced and challenging environment
  • Create the purchasing orders for all incoming shipments (API, FP and Bulk)
  • Provide administrative support to the team (e.g. booking meetings/travel/hotels)
  • Assist with the preparation of initial and ongoing institutional review board (IRB) submissions, maintains Regulatory Files for all Research Studies
  • Provides support with the training of new employees on regulatory policies and department practices
  • Responsible for the collection, filing, and maintenance, of regulatory documents
3

Experience For Regulatory Policy & Intelligence Assistant Resume

  • Design sampling processes and reports. Conduct monthly, quarterly and ad hoc reviews
  • Develop and maintain procedures and training to support compliance efforts
  • Prepare and file necessary documents related to compliance testing and audits
  • Serve as additional point of contact during compliance reviews
  • Assist in conducting Risk and Control Self-Assessment (RCSA), Bank Secrecy Act (BSA), and other assessments
  • Ensure that all SDS are updated to local requirements, consistent with the labels and available in a timely manner for submission
  • Assist with budget and other financial information as requested
  • Searches national database and creates specific databases, data collection forms, and tracking forms for research purposes. Creates spreadsheets, presentations, and administrative forms utilizing Microsoft Word, Excel, Outlook and PowerPoint. Performs other projects as assigned
4

Experience For BA Regulatory Policy Team Assistant Resume

  • Assists with the maintenance of Departmental Information ensuring up-to-date faculty CV’s, current licensures, lab certifications, lab normal and abnormal values, staff training certifications along with any additional protocol specific requirements
  • Assist in the implementation of policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards
  • Assist with the maintenance of Departmental Information ensuring up-to-date faculty CV's, current licensures, lab certifications, lab normal and abnormal values, staff training certifications along with any additional protocol specific requirements
  • Maintain complex files and electronic document management systems
  • Maintains document inventory, storage and retrieval
  • Prepares and responds to audits conducted by study sponsors
5

Experience For Scientific & Regulatory Technical Assistant Resume

  • Generate numerous standard computer reports as needed
  • Attends and participates in various in-service and external trainings, workshops, conferences and other relevant programs for professional growth and development
  • Assists in developing, implementing, and maintaining global regulatory procedures to ensure regulatory compliance
  • Assists in evaluating manufacturing changes for impact on global regulatory affairs approvals, clearances, registrations, and licenses
  • Follows regulatory plans and interfaces with department and management
  • Assists in generating and maintaining global (domestic and international) regulatory submissions, i.e. PMA, PMA supplement, PMA Annual Reports, MDR, international licenses and registrations
  • Maintains regulatory files and documents, in addition to internal regulatory tracking documents. This includes maintaining communication with supervisor and other departments to provide regulatory status reports (monthly, quarterly, etc.)
  • In addition to the required technical documentation, supplies samples, packaging, manufacturing site quality system certificates, and certificates of free sale, etc. for global product registrations
6

Experience For Regulatory / Product Steward Assistant Resume

  • Keeps abreast of regulatory requirements, this includes monitoring FDA and other agencies regulations and standards
  • Board Meeting functions include
  • Plan, organize and maintain international filing status and communication status to product development project teams
  • Access and create International registration dossiers using Coptis with accuracy and accountability
  • Daily Functions include
  • Provide regulatory documentation to international regulatory team for preparation of the local submission filings
  • Drive documentation reviews required to support international filings
7

Experience For Research Regulatory Admin Assistant Resume

  • Ensure international regulatory affairs files are updated and maintained as required
  • Develop working relationships with international regulatory team and gain understanding of the international support document necessary for each associated countries
  • Experience working in office environment or equivalent
  • Follow and understand timings from regulatory technologists to create registration dossiers when all regulatory documentation is available
  • Create registration dossiers to meet distributer requests
  • Amend registration dossier templates in case of updates/ amends
  • Create registration dossiers to meet the international regulatory requirements
  • Work closely with regulatory coordinator to ensure all Burberry beauty products are registered on time
8

Experience For Asset Management Legal Regulatory Lawyer Assistant VP Resume

  • Continuously improve and propose ways to reduce the time to carry out regulatory activities
  • Understand and use Coptis where appropriate
  • Work closely with Regulatory Coordinator and Customer operations teams to ensure registration samples and documentation are tracked to meet launch timings
  • Track, receive and save registration licences
  • Create PO and ensure they are invoiced and paid
  • Be self-driven, results-oriented with a positive outlook, and a clear focus on high quality
  • Have a Cosmetics relevant or similar education
9

Experience For Executive Assistant, Legal & Regulatory Resume

  • Have a genuine passion for the cosmetics industry
  • Develop and maintain archives of activities
  • Conduct reviews of various departments to assist in compliance policy adherence
  • Maintain and create document and submission calendar entries: proactively update document status to manage workload and provide information on specific documents’ status as it pertains to any specific submission
  • Proof reading and release of packaging materials
  • Processes new protocols by preparing submission documents to the institutional review board (IRB)
  • Preparations and implementation of regulatory working instructions and SOPs
  • Achieve a high level of technical and practical proficiency with eCTDXPress and Adobe Acrobat.
  • Acts as a liaison between the Cancer Center (YCC) and IRB to streamline the approval process by staying current with IRB requirements and addressing requests for revisions to protocol documents
10

Experience For Research Regulatory Assistant Resume

  • Maintains the YCC clinical research regulatory files (IRB approvals, amendments submissions and approvals, serious adverse event reports, safety reports, annual renewals, etc.). Provides regulatory files to study monitors and ensures compliance with study specific requirements, YCC and University polices and appropriate regulations
  • Acts as a liaison for communication regarding regulatory matters between YCC and the study sponsor including meeting with study monitors to audit regulatory files and responds to issues and queries
  • Runs special database reports for grants and other reports as requested
  • Assists the Project Manager with the development and implementation of related policies and procedures to ensure regulatory compliance and efficiency of the regulatory affairs operation. Ensure compliance with all federal and state requirements for the conduct of clinical research
  • Registers or ensures registration of clinical trials on NIH and NCI designated websites, updates and amends trial information and assists the Principle Investigator in reporting study results
  • Review of regulatory documents

List of Typical Skills For a Regulatory Assistant Resume

1

Skills For Regulatory Reporting, Assistant VP Resume

  • Project Management skills with 2-3 years experience
  • Demonstrated experience working in a positive customer service culture
  • Good experience in litigation, as well as regulatory/administrative and criminal proceedings (including AML/KYC matters)
  • Develops project management and technical writing skills
  • Five or more years of paralegal experience or relevant experience in a legal environment
2

Skills For Assistant VP Regulatory Compliance Consumer Disclosure Resume

  • Attention to detail with organizational skills
  • Able to work effectively in multinational/multicultural environments
  • Mathematical, analytical, and computer skills
  • Computer skills, especially Microsoft Word, Outlook, Access and Excel (or similar programs). Ability to navigate in various electronic databases
  • Work effectively within interdisciplinary teams
3

Skills For Regulatory Policy & Intelligence Assistant Resume

  • Challenging ways of working to ensure efficiency and effectiveness of the team is maximised
  • Testing and validation of the products intended to the certification submittal (in collaboration with the R&D leaders and Project Managers),
  • Very good writing, speaking and reading in English
  • Proven track record of mapping key stake holder and networking, utilizing network to drive SARA agenda and build company’s credibility
  • Knowledge and experience of conducing regulatory proceedings before court or other tribunals
  • Previously demonstrated advanced level multi-tasking ability in a results oriented environment
  • Managements of certificate database (certificates, test reports and their validity), indicators relating to the certification process
  • One or more years of compliance or legislative paralegal experience in the banking or financial services sector
  • Adapt and respond appropriately to competing priorities in a fast-paced environment; able to meet deadlines
4

Skills For BA Regulatory Policy Team Assistant Resume

  • Previous experience working in the pharmaceutical/ CRO industry is an advantage
  • Previous environmental planning experience
  • Experience of capital markets and/or investigation and enforcement actions undertaken within context of defined regulatory framework
  • Experience as a Regulatory Affairs assistant is an asset
  • Validation of the test methods required by the standards (new and revised)
  • Experience within regulatory affairs, Artwork creation or the pharmaceutical industry is seen as an advantage
  • Strong commercial and product awareness of product lifecycle management
  • Strong ability to manage simultaneously different tasks
5

Skills For Scientific & Regulatory Technical Assistant Resume

  • Good adaptability, analysis and synthesis
  • Experience in an academic, clinical or research environment
  • Experience with human subject/clinical research
  • 1~3 years of regulatory affairs related experience, preferably in the consumer products industry
  • Experience in product registration
  • Years of Experience: 1-2 years in healthcare
  • Relevant experience in a multinational pharmaceutical company
  • Good financial acumen and ability to assist with project budgets
6

Skills For Regulatory / Product Steward Assistant Resume

  • US Regulatory experience in Life Sciences Industry
  • US Regulatory experience in CPG or Consumer Healthcare industry
  • Demonstrated ability to work independently, under supervision, and be a team player
  • Effective communicator; able to convey messages in a logical and concise manner. Consistently reinforces regulatory expectations and requirements
  • 0-1 experience in Regulatory Affairs and knowledge of pharmaceutical regulatory Company requirements in at least one of the country is the advantage
  • Write and speak in good English
  • Administrative office experience
7

Skills For Research Regulatory Admin Assistant Resume

  • Legal, regulatory, or legislative research experience required
  • Communication skill with all levels
  • A subject matter expert for either rates or credit derivatives product line with 4-5+ years experience
  • Taking responsibility for making timely, proportionate and robust decisions based on relevant analysis
  • Writing and updating of certification technical files
  • Working knowledge of regulatory submission, compilation, publishing and approval processes, standards, systems and tools
  • Understanding of the university structure, especially the Health Science Center, Office of Research, the VA, and the IRB-02 and IRB-03
8

Skills For Asset Management Legal Regulatory Lawyer Assistant VP Resume

  • Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions
  • A comprehensive understanding of UK/IE submission requirements/procedures and Syngenta internal tracking systems
  • A comprehensive understanding of Syngenta internal booking systems/administrative processes
  • Able to work long periods of time in a normal office environment, while sitting and working on a computer
  • Professional level of English (speaking and writing)
  • English proficiency (reading and writing) is required
  • Works scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling
  • Proficiency in document manipulation using various software packages including, but not limited to, MS Word, Excel and PowerPoint
  • A comprehensive understanding of the legal requirements for labels and SDS, the triggers for change and where support can be obtained
9

Skills For Executive Assistant, Legal & Regulatory Resume

  • Knowledge of human subjects research, the regulations and policies surrounding it
  • Attention to detail and multitasking abilities, with the ability to work both independently and as part of a team
  • Support for Implementation of the certified configuration into manufacturing system
  • Carry out recurring tasks with consistent high quality
  • Attainment of a score of at least 35 cwpm on an approved typing test
  • Articulate verbally and in writing with faculty, staff, students and physicians
  • Utilize problem solving techniques and work independently
10

Skills For Research Regulatory Assistant Resume

  • Proof reading translated package leaflets, Summary of Product Characteristics and mock ups
  • Technical writing proficiency required
  • As administrative assistant, preferably in a Consulting environment, in Pharma or CRO
  • Drive and a clean DMV driving record
  • Approval of Product Approval Forms (PAFs) where applicable
  • Department: Regulatory Affairs & Quality Department
  • Reports to (hierarchically): Regulatory Affairs Manager
  • Implement case strategies and manage cases from inception to final delivery or regulatory outcome

List of Typical Responsibilities For a Regulatory Assistant Resume

1

Responsibilities For Regulatory Reporting, Assistant VP Resume

  • Provide ongoing legal assistance to the Business, including relationship managers, investment specialists, account documentation specialists, human resources, etc.
  • Excellent organizational ability, strong attention to detail and documentation skills
  • Strong computer skills and fluency in applications such as MS Word, Excel, PowerPoint, Adobe Acrobat, Outlook and Internet Explorer
  • Computer skills (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage
  • Work collaboratively, effectively and efficiently with all internal/external partners
  • Prior NM Regulatory Experience
2

Responsibilities For Assistant VP Regulatory Compliance Consumer Disclosure Resume

  • Prior experience with NMOCD website
  • Demonstrated ability in planning, tracking and delivering own work
  • Demonstrated ability in working to tight and changing timelines
  • Demonstrated competence in delivering tasks requiring attention to detail quickly and to high quality
  • Prioritize and plan on product registration and maintain an active knowledge of the status of pending approvals
  • Related experience in a clinical or research setting
  • Experience in administration
3

Responsibilities For Regulatory Policy & Intelligence Assistant Resume

  • Excellent command of both the English and Dutch language
  • Experience with FDA and OHRP regulations as well as ICH and GCP guidelines
  • Good knowledge of local registration requirements
  • Experience in the pharma or medical devices industry
  • Experience in a regulated pharmaceutical company
  • Experience with databases or data entry
  • Experience in Regulatory Affairs and knowledge of pharmaceutical regulatory requirements in at least one of the country is the advantage
4

Responsibilities For BA Regulatory Policy Team Assistant Resume

  • Assisting with creating, modifying, updating and maintaining documents
  • Copying, faxing,mailing and tracking of information
  • Preparing for monitoring or auditing visits
  • Assisting the Regulatory Specialists in screening documents for completeness and accuracy per the Regulatory Document Management Plan
  • Filing and retrieving documents, records and reports
  • Assisting the Regulatory Specialist in preparing reports to include weekly reports and other reports as requested
  • Attending internal meetings related to tasks
  • Researching FDA website for new guidances, regulations
5

Responsibilities For Scientific & Regulatory Technical Assistant Resume

  • Providing support to staff for project-based work
  • Assisting in file room as needed
  • Inputting data in various web applications and portals
  • Perform data entry, migration, manipulation, organization, reformatting, and ongoing maintenance in various systems/databases
  • 3) Assist Regulatory Specialists with sponsor and/ or CROs during monitoring visits
  • MBO+ / HBO level of thinking and working
6

Responsibilities For Regulatory / Product Steward Assistant Resume

  • Flair for details and be capable of working with many assignment at the same time without losing overview
  • Process existing and new investigator credentialing documents in order for them to participate on research studies
  • Assist Regulatory Specialists with sponsor and/ or CROs during monitoring visits
  • Assists with study close-out activities, including updating pharmacy and other ancillary departments of study status at study termination
  • Oversees data cleaning procedures and reports on quality/integrity of data through recruitment tracking reports and periodic conduct-of-study reports
  • Ensures compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to
  • Management of communication flow with the Competent Authorities regarding the registrations
  • Respond to customer inquiries regarding regulatory issues
  • Assist in preparing files for CAPA and NODCAR for submission, and request columns or reagents from vendors
7

Responsibilities For Research Regulatory Admin Assistant Resume

  • Submission of clinical trials and getting import license approval for samples used in clinical trials
  • Align the submission of the promotional materials with the Marketing team
  • Assist the Marketing team in submission of the promotional materials at the MOH
  • File and archive the promotional materials, and serialize the received approvals from the MOH for printing
  • 5) Assist research teams in preparing for DMG meetings
  • Receives, reads, dates and sorts incoming mail and overnight delivery. Prepares and readies letters and packages for overnight delivery
  • Co-manages the processing of payment requests, travel expense reports, documents for signature, and international travel arrangements
  • Maintain QA filing systems in accordance with established company internal standards
  • Maintenance of Admin databases / filling systems / group inboxes
8

Responsibilities For Asset Management Legal Regulatory Lawyer Assistant VP Resume

  • Give internal pharmaceutical and regulatory service to Marketing, Supply Chain and QA
  • Collect, revise and maintain files of regulatory documents and protocol specific training documentation
  • Facilitate the execution of required regulatory documents, such as obtaining signatures
  • Preparation and implementation of local processes, ways of working and work instructions
  • Facilitates pre-study meeting with investigators
  • As directed by Federal Registrations Manager, prepare the product labels for submission to EPA following FIFRA regulations
  • Primary focus is providing complex administrative support for individuals and/or department
9

Responsibilities For Executive Assistant, Legal & Regulatory Resume

  • Serves as regulatory consultant to marketing team
  • Works to established timelines for submissions, escalating where necessary to minimize delays
  • Organizes and maintains reporting schedules
  • Ability for multiple project tasking
  • Support brand marketing teams to review Chinese labels. Make sure all contents, especially claims, are complied with local regulations
  • 6) Ad and Packaging registration
  • Measure package of sets and inform brands if the package is complied with local excessive packaging restrictions and give advice
  • A comprehensive understanding of Syngenta procedures for label and SDS production
  • Maintain internal tracking systems for exams and MRA’s
10

Responsibilities For Research Regulatory Assistant Resume

  • Preparation, submission and follow-up of registration files
  • Ensure all systems are in place to meet all Corporate Governance requirements
  • O Provides regulatory support to Regulatory Specialists and internal PPD Project team in preparation, planning and coordination of regulatory documentation from provision from a client to timely submission of final document back to client or relevant Regulatory Authorities
  • Coordinate with translators and qualify the appropriate vendors for translation of all documents as per MOH regulations and business need
  • Provide import license approval and the release of the samples for registration
  • Prepare the Pharmacovigilance pre-audit documents and ensure the content of the files

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