Director of Regulatory Affairs — NDA Submissions & Strategy
Viking Therapeutics, Inc.
Viking Therapeutics, Inc. in San Diego, CA, is seeking a Director of Regulatory Affairs to lead global regulatory strategy, oversee NDA filings, and coordinate health authority interactions. The role includes managing submission documents, lifecycle planning, and supervising external publishing vendors within a lean sponsor-operating model. The candidate will mentor teams, contribute to IND/NDAs, and ensure compliance with FDA/ICH guidelines in a fast-paced environment. #J-18808-Ljbffr Viking Therapeutics, Inc.
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Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco,... ...as planning for future MAA/NDA/BLA(s). This role requires... ...through QC review of submission components, including CMC... ...global regulatory filing strategies. Collaborate cross-functionally...Temporary workCasual workLocal areaRemote workWorldwideFlexible hours$150k - $195k
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...service for rare patients.Position Summary:The Executive Director, R&D Strategy & Operations, serves as the strategic partner and Chief of... ..., Clinical Pharmacology, Biometrics, Pharmacovigilance, Regulatory Affairs, Quality, and Medical Affairs.As a cross-functional strategic...Full timeTemporary workWork at officeRemote work- A leading staffing solutions provider based in San Diego is looking for a Regulatory Affairs Associate. This role involves providing regulatory support for US and global submissions, ensuring full compliance with documentation. Candidates should have a Bachelor's degree...Hourly payContract work
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