Director, Regulatory Strategist- Oncology

Groton, Connecticut
September 21 2021
Position Type
Full Time
Organization Type

We have an exciting opening for a highly visible Regulatory Strategist role supporting early and late stage development assets. In a Director level position, this individual will serve as a Global Regulatory Lead on multifunctional and key project teams in the oncology therapeutic area, providing regulatory expertise. Activities may also involve regional focus for the US or EU. The incumbent will develop and deliver regulatory strategies for Phase 1 through Phase 4 development stages and manage all regulatory aspects of projects, including the preparation and submission of correspondences and applications to regulatory agencies. They will also act as direct liaison with FDA, EMA and other Health Authorities to facilitate the prompt review and approval of applications. This successful candidate will have deep understanding of the regulatory environment and the ability to communicate priorities to stakeholders.

  • Accountable for leading the preparation of Global Regulatory Strategies and implementation plans (core labels, risk registers) for assigned projects.
  • Partner with project teams and other customers (e.g., Oncology Research Unit/Pfizer Oncology, Regional Commercial Teams) to ensure regulatory contributions (Global Regulatory Strategies, labels, INDs, CTAs, BLAs/NDAs, MAAs, sNDAs, etc.) meet business needs and are provided within agreed time, cost and quality standards.
  • Develop and maintain constructive working relationship with Health Authority contacts.
  • Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the business are championed and communicated.
  • Work closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
  • Ensure business compliance, and implementation of and adherence to regulatory standards.

  • BS with 14+ years, Masters with 12+, or PhD/equivalent with 9+ years of experience required.
  • Prior oncology drug development experience preferred. Immuno-oncology experience beneficial.
  • Proven examples of delivery with demonstrable contribution in global Regulatory activities, including knowledge of IND/CTA, BLA/NDA/MAA and other submission processes.
  • Proven ability to manage complex regulatory issues.
  • Proven ability to consistently deliver within time, cost and quality standards.

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.

Other Job Details
  • Last Day to Apply for Job: September 24th 2021
  • Additional Location Information: La Jolla, CA; New York, NY; Collegeville, PA; Groton, CT; Milan, Italy; Walton Oaks, UK, Sandwich, UK, US Remote, UK Remote
  • Eligible for Employee Referral Bonus

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Regulatory Affairs