Regulatory Affairs Officer 2

Iqvia Holdings Inc San Diego , CA 92140

Posted 2 months ago

Job Profile: Grade 140 Reg Officer 2 - US Maintenance GRL

Expertise

  • Degree in life science-related discipline or professional equivalent

  • Minimum of 3 years in US regulatory lifecycle maintenance experience, focusing on US marketed products

Technical Experience

  • Experience in regulatory procedures in the US within regulatory lifecycle maintenance activities including Annual Report authoring and co-ordination, knowledge of IND, NDA, BLA applications working cross-functionally with other regulatory stakeholders e.g. Global Regulatory Lead (GRL), CMC, Labelling, Non-Clinical, Clinical, Publishing etc.

  • Preferably has experience in managing small regulatory projects

  • Interaction with Regulatory Agencies i.e. FDA is desirable but not a must

  • Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets

  • Experience in quality review of technical / regulatory documents

  • Experienced working in regulatory electronic systems such as RIM, document management systems (EDMS), publishing viewer

  • Able to assist in review and revision of regulatory and client SOPs / act as reviewer as appropriate

Core responsibilities

  • Coordinate several US Annual reports (AR) for IND, NDA, BLA applications to be submitted to FDA for the marketed products portfolio involved in notification, preparation, authoring, compilation and final publishing working cross-functionally with the client GRLs and Functional Area Leads (FALs)

  • Arrange, prepare content and lead Kick-off meetings per AR with FALs discussing timelines, roles and responsibilities, issues etc.

  • Draft cover letters, forms, document plans required for submission

  • Ensure electronic databases, trackers and systems for product portfolio are appropriately managed and maintained in a timely and organized manner

  • Escalate issues early to the Workstream lead mitigating risks

  • Provide support to the Workstream lead, as needed

Soft Skills

  • Excellent verbal and written communication skills in English are essential

  • Well organized

  • Be able to manage peaks of workload and prioritize workload with some supervision

  • Ability to work to tight timelines

  • Open and communicative personality

  • Good team player

  • Good negotiating skills

  • Ability to identify issues and contribute to their resolution

  • Strong computer skills, including MS Office applications, project management tools (trackers), data and document management systems, SharePoint

  • Adaptable to change

  • Cultural awareness

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Manager Regulatory Affairs

Thermo Fisher Scientific Inc.

Posted 1 week ago

VIEW JOBS 1/12/2021 12:00:00 AM 2021-04-12T00:00 Job Description 142906BR - Sr. Manager Regulatory Affairs San Diego What will you do? * Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed. * The delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals. Incumbent will serve as a member of the Global Regulatory department. * Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams * Document regulatory strategies for product submissions. * Facilitate and prepare U.S. regulatory Pre Submission documents for Next Generation Sequencing and/or PCR assays * Facilitate FDA pre submission meetings * Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays * Support EU representatives in their creation of CE/IVD Technical Files * Support global regulatory registration representatives for product global registration activities * Perform regulatory assessment of new and changed products. * Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. * Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team's knowledge of working in a regulated environment. * Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures. * Participate in business meetings with potential new external partners Education * A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. How will you get here ? * Must have a minimum of 8 years of IVD Regulatory Affairs experience. * This experience must include either 510(k), PMA, PMA supplement submissions. Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements. * Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies. * Experience in the balance and application of regulatory requirements * Direct and positive experience in communicating with Regulatory Authorities and co-development partners. * Regulatory review of promotional marketing materials, press releases, labeling, etc. * Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices. * Capacity to communicate regulations to technical functions within the company Knowledge, Skills, Abilities * Hands-on, action-oriented, and able to implement effectively through his/her team * Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency * Able to work autonomously in a matrix-managed organization * Ability to provide solutions based on knowledge of regulation and industry experience * Willingness to travel (~10-15%) * Comfortable with ambiguity and change * EVAMOPS2020 *GTSDouble Thermo Fisher Scientific Inc. San Diego CA

Regulatory Affairs Officer 2

Iqvia Holdings Inc