Accountable for ensuring US/regional contribution to Global Regulatory Strategies and implementation plans
Ensures regulatory contributions achieve the objectives in the strategy
Maximize overall project delivery time and probability of success
Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports
Monitor regulatory plans and communicate progress/variance to Global Regulatory Lead and Senior Management
Engage with appropriate activities to influence the regional regulatory environment
Develop and maintain constructive working relationship with Health Authority contacts in the assigned region

Bachelor's degree with at least 2 years of experience
Effective delivery in a complex matrix environment
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 and in different stages of the product life cycle is highly desirable
Experience in communicating with FDA and participating in/leading such interactions is preferred
In-depth understanding of national and regional regulatory legislation and guidelines
Proven ability in developing and implementing regulatory strategy
Experience preparing and submitting INDs and/or CTAs, NDAs, amendments/supplements is preferred
Must have effective communication skills and presentation skills

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

Senior Associate, Global Regulatory Strategy – Oncology

Key skills