Vice President, Internal Medicine Regulatory Strategy

Role Summary

Vice President, Internal Medicine Regulatory Strategy. Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global development that changes patient lives throughout the product life cycle. This role provides regulatory guidance to Pfizer’s Internal Medicine portfolio including metabolic disease, cardiovascular risk, diabetes and cachexia, with a focus on approvals and optimal labeling for the portfolio.

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, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs
• Subject-matter expertise within assigned therapeutic area includes global regulatory strategy experience in the cardiovascular, renal and metabolic disease (CVRM) areas. Has significant experience and track record of achievements in the chronic weight management area and GLP-1 landscape, through prior regulatory experience, and direct product development
• Proven track record of success in negotiating with global health authorities and in representing interests to external stakeholders
• Demonstrated strategic thinking and ability to integrate strategies into actionable plans
• Proven 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
• Proven ability to lead with an innovative and agile mindset as well as creatively execute strategic plans

Organizational Relationships

• Reports to Head, GRS
• Member, GRS Leadership Team
• Member, IM Leadership Team
• Works with all relevant stakeholders including Chief Internal Medicine Officer, Finance, PX, Legal, and PGS
• Works with external contacts including Regulatory Authorities (FDA, EMA, MHLW etc), professional scientific and regulatory groups, trade associations and consultants

Resources Managed

• Resources managed is ~15 colleagues