Vice President, Vaccines, Anti-infectives & Global Brands Regulatory Strategy

Role Summary

Global Regulatory Sciences (GRS) serves as a strategic leader and catalyst, enabling high-quality, efficient, and innovative, label-focused global development that changes patient lives throughout the product lifecycle. The role leads regulatory affairs capability for Vaccines, Anti-infectives & Global Brands programs, with global responsibility for the Business Unit Head or R&D organization, and oversees regulatory resources, strategy, and alignment across regions to optimize development and commercial decisions and approvals for Pfizer products.

Responsibilities

• Represents GRS as leader for Vaccines, Anti-infectives & Global Brands programs
• Convenes GRS leadership team to maintain a collaborative, performance-oriented culture that embodies Pfizer Values
• Owns global resource allocation to projects and product teams
• Participates as a GRS member in development of global strategies and translates those into region/site-specific deliverables
• Responsible for global regulatory project/product governance
• Engages to influence the regulatory environment
• May assume responsibility for other activities/functions within GRS as required
• Ensures development of all GRS staff to help them achieve their full potential

Qualifications

• MD, PhD, PharmD degree, or equivalent, with experience in drug development/commercialization and ongoing regulatory education
• Minimum 10 years’ experience in an industry regulatory affairs function and/or a major regulatory agency
• Regulatory experience with drugs across life cycle and involvement in FDA Advisory Committee and other major Health Agencies’ hearings
• Proven drug development experience or relevant experience within the Pharmaceutical industry/FDA/EMA
• Proven track record of successful management of staff and complex regulatory issues
• Proven business management capability

Skills

• Regulatory Experience – with drugs across life cycle, Advisory Committee and other Health Agency hearings
• Strong logical and analytical skills for solving difficult problems and delivering effective solutions
• Communications – ability to convey complex information to scientific and non-scientific audiences
• Regulatory Infrastructure – understanding of processes essential for maintaining strong regulatory representation on project teams
• Line Management/Supervision – mentoring staff, clear assignment of responsibilities, objective setting and performance monitoring
• Network and Alliance Building/Peer Relationships – ability to interact across disciplines to establish policy

Additional Requirements

• Work Location: Hybrid role requiring residence within commuting distance; on-site approximately 2.5 days per week or more as needed