Senior Vice President of Regulatory Affairs

1 week ago


Waltham, Massachusetts, United States Meet Full time

Senior Vice President of Regulatory Affairs

*Candidates should be located in New England or must be open to travel*

Primary Responsibilities

  • Provide strategic oversight and regulatory guidance to the Regulatory Affairs, Clinical Quality, and Medical Writing teams while leading the Regulatory Affairs division, including recruitment, mentorship, and team leadership.
  • Facilitate the organization and execution of discussions with regulatory bodies, ensuring effective representation of the organization’s regulatory engagements.
  • Oversee and negotiate submissions (IND, CTA, BLA, MAA, etc.) and secure approvals from regulatory agencies.

Essential Qualifications

  • Bachelor's degree required; advanced degrees (MS/PhD/PharmD) preferred.
  • Over 15 years of experience in Regulatory Affairs.
  • Proven experience in virology and infectious diseases is essential.
  • Demonstrated ability to lead programs from Initial IND/CTA through to BLA/MAA.
  • Extensive experience interacting with Health Authorities (FDA, EMA, Health Canada).


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