Director, Regulatory Affairs

Our client is a heavily-funded research and development company whose mission is to harness advanced systems and technologies to increase their understanding of human aging. Our client will use this knowledge to devise interventions allowing people to live longer, healthier, and happier lives! About the Job: The Senior Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies to accelerate clinical development and ensure seamless commercialization. This role requires a blend of deep scientific fluency spanning across both small molecules and biologics, meticulous attention to detail, and the ability to effectively and efficiently negotiate with global health authorities. Responsibilities of This Role: Meticulously design and implement top-notch global CMC regulatory strategies to secure approvals and maintain compliance for clinical and commercial products, identifying any and all potential risks. Expertly lead and provide guidance on CMC requirements for both Small Molecules and Biologics sectors. Enthusiastically be the primary CMC point of contact for any and all relevant global health authorities. Thoughtfully define any and all necessary data packages to support post-approval supplements. Diligently draft and author and direct preparation and technical review of CMC sections for global filings: Investigational applications for early-phase trials Marketing applications for any and all relevant major markets Actively manage the lifecycle of the Common Technical Document (CTD) specifically focusing on Modules 3 and 2.3. Thoughtfully collaborate with any and all of our client's internal teams when necessary. Carefully provide regulatory risk assessments for various manufacturing scenarios. Actively monitor and stay current on any and all relevant evolving regulations. This Role is for you if you Have: B.S./M.S. in a scientific discipline (Chemistry, Biology, or Pharmacy); Ph.D. or PharmD highly preferred. 15+ years of experience in the biopharmaceutical industry, AND 9+ years focused specifically on CMC Regulatory Affairs. A successful history of contributing to least two major marketing application (NDA, BLA, or similar) throughout the entire process. Deep knowledge of small molecule and mAbs modalities. Exceptional communication and interpersonal skills, with the ability to effectively interact cross-functionally with stakeholders and senior leadership, CMOs, and regulatory authorities. Are willing to work a hybrid or in person model with a minimum of 3-4 days per week onsite. Are local to or willing to relocate to the San Francisco Bay Area with aid from a generous relocation assistance package from our client. Compensation: The estimated base salary range for this role is $275,000 - $280,000 per year. Actual pay will be based on several factors including but not limited to experience and qualifications. This position is also eligible for 2 annual bonuses! #J-18808-Ljbffr