Vice President, Internal Medicine Regulatory Strategy

JOB SUMMARY

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.

The Vice President, Internal Medicine Regulatory Strategy, serves as a senior regulatory leader who has global mindset and expertise of drug development and product lifecycle processes in support of Pfizer’s Internal Medicine portfolio including metabolic disease, cardiovascular risk, diabetes and cachexia.  The goal of position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products to optimize input to development and commercial decision-making and ultimately lead to approvals with optimal labels for Pfizer’s Internal Medicine portfolio.

This includes a track record of successful regulatory achievements in developing and registering drugs or biologics indicated for chronic weight management, obesity or other metabolic- related conditions  a leading and respected voice that has influenced regulatory policy associated with obesity/chronic weight management development,  and evidence of prior role as senior level point person for addressing commercial needs globally for all products and projects in an advanced obesity pipeline.

This leader will: 

• 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 (e.g., membership in advisory councils and/or trade associations) 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 

JOB RESPONSIBILITIES

·       Provides regulatory expertise and leadership within the assigned portfolio, and other disease areas as relevant including ensuring global regulatory strategies for all projects and products within the assigned portfolio, as relevant are developed and implemented

·       Responsible for developing and maintaining an in-depth regulatory knowledge of the portfolio including current and emerging global guidelines and regulator’s latest thinking, relevant regulatory approaches and actions; and status of competitor products

·       Partners with leaders in R&D and Commercial teams to develop strong global regulatory strategies for projects and products.

·       Engages in appropriate activities to influence the regulatory environment including developing strong working relationships with regulators, professional bodies, external experts and opinion leaders.

·       Owns resource allocation for GRS IM

·       Champions flexible approaches to ensure efficient and effective resource utilization.

·       May assume responsibility for other activities/functions within GRS as required.

Ensures development of all staff functional line help them achieve their full potential.

QUALIFICATIONS / SKILLS

• Advanced Scientific Degree (M.D., Ph.D., PharmD) with a minimum of 10 years’ 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

The annual base salary for this position ranges from $280,400.00 to $467,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Regulatory Affairs