Senior Vice President of Regulatory Affairs
1 week ago
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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