Pfizer

Vice President, Global Regulatory Affairs - Vaccines

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Posted
June 09 2021
Ref
4815556
Position Type
Full Time
Organization Type
Pharma
The purpose of the position is to lead Pfizer's Global regulatory affairs capabilities and strategies for the Vaccines Research and Vaccines Business Units. The incumbent serves as a senior regulatory leader who has global mindset and expertise of vaccine development and product lifecycle processes and priorities, regulatory environmental issues, as well as commercial needs globally for Pfizer's growing vaccine portfolio, including the Pfizer/BNT COVID-19 vaccine. The ultimate goal of the position is to provide, maintain, manage, and direct regulatory resources in the provision of regulatory guidance in order to optimize the end-to-end vaccine clinical development and commercial decision-making and ultimately lead to timely approvals with optimal and competitive labels. This role directly oversees and manages ~25 global regulatory strategists and reports to Pfizer's Head of Global Regulatory Affairs.

Primary Responsibilities:
  • Represents GRA as single point of contact for BU or RU (WRD).
  • Convenes GRA 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 GRA 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.
  • Effective communication and collaboration of the GRA groups and ensure that all regulatory deliverables are of high quality and optimally coordinated. He/she conducts 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 the SVP WW Medical Excellence and senior leaders within the BU/RU.
  • Responsible for staff and talent management, career development and planning and performance management.
  • Accountable 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.
  • Business management accountability, manage budget and costing structure for contribution of services of each BU.
  • Ensures appropriate alignment of roles, responsibilities, and deliverables to the projects/products and to global GRA. 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.
  • Accountable for ensuring that any site/region considerations for all projects and products are reflected in the relevant global regulatory strategy.
  • Represent GRA 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 GRA as well as the processes and policies to represent the priorities of all regions within the global GRA department.
  • Engages in appropriate activities in order to influence the regulatory environment.
  • May assume responsibility for other activities/functions within GRA as required.
  • Ensures development of all staff in BU or RU to help them achieve their full potential.


Requirements:
  • 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 problem 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 communication 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 GRA 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 and optimize processes.


Qualifications:
  • 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.
  • 15+ years 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


Last Date to Apply: 6/16/2021

#LI-PFE

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Regulatory Affairs

Similar jobs

Similar jobs