Senior regulatory leader responsible for global regulatory affairs of Vaccines and Anti-infectives at Pfizer. Collaborating with leadership and managing resources for optimal regulatory support.
Responsibilities
Represents GRS as leader for Vaccines, Anti-infectives & Global Brands 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 in global strategies and translates those into region and possibly site-specific deliverables.
Responsible for global regulatory project/product governance.
Engages in activities to influence the regulatory environment.
Ensures development of all GRS staff to help them achieve their full potential.
Requirements
MD, PhD, PharmD degree, or equivalent, with experience in drug development/commercialization and a record of continuous learning and education regarding regulatory processes and policies.
Minimum 10 years’ experience in an industry regulatory affairs function and/or a major regulatory agency.
Regulatory experience - with drugs across life cycle, FDA Advisory Committee and other major Health Agencies’ hearings.
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.
Proven business management capability.
Strong logical and analytical skills.
Excellent communication skills.
Understanding of and experience with processes and interactions essential for maintaining strong and comprehensive regulatory representation on project and product teams.
Able to mentor less experienced staff and assign responsibility for tasks and decisions effectively.
Benefits
Health benefits to include medical, prescription drug, dental and vision coverage.
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
Paid vacation, holiday and personal days.
Paid caregiver/parental and medical leave.
Eligibility to participate in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary.
Eligibility to participate in our share based long term incentive program.
Job title
Vice President, Vaccines, Anti-infectives – Global Brands Regulatory Strategy
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