Pfizer

Senior Director, Global Regulatory Lead

Employer
Pfizer
Location
New York City, New York; Groton, Connecticut
Salary
Competitive
Posted
September 09 2021
Ref
4823969
Position Type
Full Time
Organization Type
Pharma
Senior Director, Global Regulatory Lead, COVID-19 Vaccine

Please Note: This is a Clinical Regulatory Affairs position, not a CMC/Facilities Regulatory Affairs position. The candidate must be able to provide operational and strategic Regulatory leadership and contribution to the areas of global clinical development, registration plans, labelling, licensure, and post-marketing commitments/post-authorization safety surveillance.

ROLE SUMMARY
  • Provide strategic regulatory expertise as Global regulatory representative to Product Team(s).
  • Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from North America, Europe, Emerging Markets, Japan.
  • Through the GRST, develop, align, manage and implement the global regulatory strategy.
  • Be accountable for delivering the project goals and aligning the regulatory strategy with global and business regional needs.
  • Be accountable for timely submissions and approvals with commercially attractive labelling across the regions.
  • Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).
  • Role may be combined with other Regulatory Role (i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).
  • Project(s) assigned can be in development and/or at post-authorization stage


ROLE RESPONSIBILITIES
  • Responsible for the production, updating and communication of global regulatory strategies for assigned projects/ products, mechanisms of action and/or indications.
  • Provides regulatory expertise and leadership for the project/product.
  • Member of appropriate Project(s)/Product(s) teams.
  • In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy.
  • Ensures appropriate representation for Pfizer for the project/product with Health Authorities.
  • Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.
  • Ensures that all regulatory development process commitments are clearly communicated, monitored and met.
  • Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy
  • Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives.
  • Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders.
  • Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRPL and other stakeholders as required.
  • Participates in appropriate governance committees, as necessary.


QUALIFICATIONS
  • BS is required. MS, PharmD, or PhD preferred. 15 years of relevant work experience required.
  • Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST.
  • Advanced knowledge of US FDA regulations required, advance knowledge also including EU and additional global Health Authority regulations preferred.


Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Additional Job Information
  • Last date to apply: September 22, 2021
  • Eligible for employee referral
  • #LI-PFE


Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

#LI-PFE

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