Director/Senior Director, Regulatory Affairs

Director/Senior Director, Regulatory AffairsHybrid Opportunity - 3x per week onsite in SF Bay AreaMeet has partnered with an exciting, early-stage biotech focused in the oncology space. They are looking for a Director or Senior Director of Clinical Regulatory Affairs to join their team.Key Responsibilities:Develop and execute Clinical Regulatory Affairs strategies to support clinical development objectivesServe as the direct point of contact with the FDA, managing all HA interactions and lead the development of major submissions (IND/CTA/BLA/MAA)You will provide guidance to other members of the senior/executive leadership team to communicate risks and advise on proper regulatory pathwaysKey Qualifications:Minimum 7 years specifically in clinical regulatory affairsOncology experience requiredSmall biotech experience highly preferredLeadership + team management experience highly preferredPlease reach out to Ryan Moran to learn more about this opportunity:: ryan.moran@peoplewithchemistry.com

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