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About the role
Key responsibilities & impact- Represents GRS as leader for Vaccines programs.
- Convenes GRS leadership team assuring the establishment and maintenance of a collaborative performance-oriented culture.
- Owns global resource allocation to projects and product teams.
- Participates in the development of global strategies and translates those into region and possibly site-specific deliverables.
- Responsible for global regulatory project/product governance and governance processes.
- Engages in activities to influence the regulatory environment.
- Ensures development of all GRS staff to help them achieve their full potential.
Requirements
What you’ll need- Bachelor’s degree with 15+ years, OR Master’s degree with 13+ years, OR PhD/PharmD/MD with 10+ years' experience in drug development/commercialization.
- Minimum of 10 years’ experience in an industry regulatory affairs function and/or a major regulatory agency.
- Proven examples of drug development experience or other relevant experience within the pharmaceutical industry/FDA/EMA.
- Proven track record of successful management of staff and complex regulatory issues.
- Regulatory experience with drugs across life cycle, FDA Advisory Committee and other major Health Agencies’ hearings.
- Strong logical and analytical skills.
- Excellent communication skills.
Benefits
Comp & perks- Health benefits to include medical, prescription drug, dental and vision coverage.
- 401(k) plan with Pfizer Matching Contributions.
- Additional Pfizer Retirement Savings Contribution.
- Paid vacation, holiday, and personal days.
- Paid caregiver/parental and medical leave.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug developmentregulatory affairsregulatory project governanceresource allocationglobal strategiesFDA regulationsEMA regulationsregulatory complianceperformance managementstaff development
Soft Skills
leadershipcollaborationanalytical skillscommunication skillsinfluencingproblem-solvingstrategic thinkingteam managementorganizational skillsperformance-oriented culture
Certifications
Bachelor’s degreeMaster’s degreePhDPharmDMD
