Vice President, Internal Medicine Regulatory Strategy

Role Summary

Vice President, Internal Medicine Regulatory Strategy — senior regulatory leader with global mindset supporting Pfizer’s Internal Medicine portfolio including metabolic disease, cardiovascular risk, diabetes and cachexia. Leads regulatory guidance to optimize input to development and commercial decision-making and aims for approvals with optimal labels. Focused on obesity/chronic weight management and related regulatory policy influence.

Responsibilities

• Ensure regulatory input is effectively articulated and reflected in clinical development plans to support clear and decisive development and commercial decision-making
• Gain timely approvals with optimal labels for Pfizer products through use of innovative pathways and effective regulatory support for product registration
• Balance portfolio priorities by allocating and directing resources to assure qualified regulatory representation and support
• Ensure compliance of marketed products throughout the product lifecycle and support regulatory product defense activities as needed
• Engage in regulatory policy priorities by representing Pfizer in scientific or regulatory activities to influence the regulatory environment
• Partner across GRS to ensure regulatory deliverables for submissions and special projects are high quality and well coordinated
• Serve as key partner for Internal Medicine R&D, U.S. Commercial, and other stakeholders, communicating regulatory implications of emerging data and external regulatory changes
• Champion growth and career development for colleagues in GRS

Qualifications

• Advanced Scientific Degree (M.D., Ph.D., PharmD) with a minimum of 10 years‚Äô experience in drug, device, development and/or commercialization
• Preferred: 20+ years in drug and/or device development or relevant pharmaceutical industry experience, ideally in Regulatory Affairs
• Subject-matter expertise in cardiovascular, renal and metabolic diseases (CVRM) with significant experience in chronic weight management and GLP-1 landscape
• Proven track record of negotiating with global health authorities and representing interests to external stakeholders
• Demonstrated strategic thinking and ability to translate strategies into actionable plans
• Ability to function autonomously at a senior level in a highly matrixed organization
• Experience in managing staff and complex regulatory, program management or business issues
• Ability to lead with an innovative and agile mindset and execute strategic plans

Skills

• Regulatory strategy and global submissions
• Stakeholder management and cross-functional collaboration
• Regulatory policy engagement and external advocacy
• Resource planning and leadership in a matrix environment

Education

• Advanced scientific degree required (M.D., Ph.D., PharmD)

Additional Requirements

• Experience with regulatory authorities (FDA, EMA, MHLW, etc.) and external regulators
• Ability to travel as needed for regulatory activities and leadership responsibilities