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

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. This position reports to a Sr. Vice President, GRS.

Member of the GRS Leadership Team and RU Leadership Teams. Partners with other Global Regulatory Leaders and RU Heads to assure consistent professional and appropriate regulatory support and cross TA portfolio oversight. Works with all relevant GRS contacts and other internal contacts. Works with external contacts including Regulatory authorities (FDA, EU, MHLW, etc.), professional scientific and regulatory groups, trade associations, and consultants.

PURPOSE

The purpose of the position is to lead regulatory affairs capability for Vaccines, Anti-infectives & Global Brands programs. The incumbent would typically have the single point accountability for the Business Unit Head (or for R&D organization). The incumbent serves as a senior regulatory leader who has a global mindset and expertise of drug development and product lifecycle processes and priorities, regulatory environmental issues, as well as commercial needs globally for all products and projects related to Vaccines, Anti-infectives & Global Brands programs.

The ultimate goal of the position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products so as to optimize input to development and commercial decision-making and ultimately lead to approvals with optimal labels for Pfizer products, support marketed products at times of product defense activities and oversee more routine regulatory maintenance activities for products later in their life cycle.

The incumbent represents GRS on senior leadership committees and meetings within or across the different Pfizer Divisions. The remit is to appropriately represent the processes, policies and project/product deliverables of GRS as well as the processes and policies to represent the priorities of all regions within the global GRS department. The leader will manage all GRS staff within their functional line. In this role they ensure appropriate alignment of roles, responsibilities, and deliverables to the projects/products and to global GRS.

This position balances priorities within and across regions, using load-sharing and job sharing, to assure qualified regulatory representation for each product or project, pre- or post-approval. The leader is accountable for ensuring that any site/region considerations for all projects and products are reflected in the relevant global regulatory strategy. The incumbent is responsible for the effective communication and collaboration of the GRS groups and ensure that all regulatory deliverables are of high quality and optimally coordinated.

They conduct timely and efficient internal communication of resource and data quality matters, issues relating to the regulatory implications of emerging data, and implications of external regulatory environment changes to senior leadership in relevant therapeutic area. The leader is responsible for staff and talent management, career development and planning and performance management.

This leader takes accountability for regulatory policy issues by making a commitment to represent Pfizer in appropriate scientific or regulatory activities (e.g., membership in internal advisory councils and/or external association) to influence the regulatory environment. The incumbent has business management accountability as he/she needs to manage budget and costing structure for contribution of services of each BU.

JOB RESPONSIBILITIES

• Represents GRS as leader for Vaccines, Anti-infectives & Global Brands programs.
• Convenes GRS leadership team assuring the establishment and maintenance of a collaborative performance oriented culture that embodies Pfizer Values and Leader Behaviors.
• Owns global resource allocation to projects and product teams.
• Participates as a GRS member in the development in global strategies and translates those into region and possibly site-specific deliverables.
• Is responsible for global regulatory project/product governance, and global governance as appropriate.
• Engages in appropriate activities in order 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 / SKILLS

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

Technical Skills

• Regulatory Experience – with drugs across life cycle, Advisory Committee and other Health Agency hearings.
• Strong logical and analytical skills – uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at first answers.
• Communications – able to communicate complex information and analyses to a variety of scientific and non-scientific audiences.
• Regulatory Infrastructure – understanding of and experience with processes and interactions essential for maintaining strong and comprehensive regulatory representation on project and product teams.
• Line Management/Supervision – able to mentor less experienced staff to represent the full knowledge and experience base of GRS in their team interactions; clearly assigns responsibility for tasks and decisions, sets clear objectives and measures, monitors process, progress and results; strong and proven abilities in Line Management with excellent teaching and coaching skills.
• Network and Alliance Building/Peer Relationships – able to interact with a variety of disciplines to establish policy.

Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.