Vice President, Internal Medicine Regulatory Strategy

Role Summary

Vice President, Internal Medicine Regulatory Strategy

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 innovative pathways and effective regulatory support for product registration
• Effectively balance portfolio priorities by dynamically 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
• Take an active role in regulatory policy priorities by representing Pfizer in appropriate scientific or regulatory activities to influence the regulatory environment as appropriate
• Partner across GRS to ensure that all regulatory deliverables for submissions and special projects are of high quality and optimally coordinated
• Serve as key partner for Internal Medicine R&D, U.S. Commercial, and other key functional stakeholder, regularly communicating the regulatory implications of emerging data, and implications of external regulatory environment changes to appropriate stakeholders
• Champion growth and career development for colleagues in GRS

Qualifications / Skills

• 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 demonstrable experience in drug and/or device development or relevant experience in the pharmaceutical industry, ideally within Regulatory Affairs
• Subject-matter expertise within assigned therapeutic area includes global regulatory strategy experience in the cardiovascular, renal and metabolic disease areas; significant experience in chronic weight management and GLP-1 landscape
• Proven track record of success in negotiating with global health authorities and representing interests to external stakeholders
• Demonstrated strategic thinking and ability to integrate strategies into actionable plans
• Ability to function autonomously at a senior level in a highly matrixed organization
• Proven track record of successful management of staff and complex regulatory, program management or business issues
• Ability to lead with an innovative and agile mindset and execute strategic plans

Organizational Relationships

• Reports to Head, GRS
• Member, GRS Leadership Team
• Member, IM Leadership Team
• Works with stakeholders including Chief Internal Medicine Officer, Finance, PX, Legal, and PGS
• Engages with external regulators and professional groups

Resources Managed

• Resources managed is ~15 colleagues