Overall regulatory lead for the Fertility Equipment business unit and UK - based regulatory team. Responsible for compliance and regulatory strategies for various markets.
About the role
- Regulatory Associate managing US/regional contributions to Global Regulatory Strategies and implementation plans at Pfizer. Collaborating with cross-functional teams ensuring compliance with regulations while advancing patient access.
Responsibilities
- Accountable for ensuring US/regional contribution to Global Regulatory Strategies and implementation plans
- Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports
- Work with a degree of independence on moderately complex assignments
- Ensure an aligned regional regulatory position for assigned projects
- Engage with OGRS-In Country colleagues, Agency contacts, and Trade Associations
- Ensure business compliance and adherence to Regulatory standards
- Develop and maintain constructive working relationships with Health Authority contacts
Requirements
- Bachelor's degree with at least 2 years of experience
- Regulatory experience including knowledge of New Drug Application (NDA) and Investigational New Drug (IND) submission processes
- Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas
- Equivalent experience at a regulatory agency or substantive industry-government collaborations
- Experience communicating with FDA and leading such interactions
- In-depth understanding of national and regional regulatory legislation and guidelines
- Proven ability in developing and implementing regulatory strategy
- Experience preparing and submitting INDs/CTAs, NDAs, amendments/supplements preferred
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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