Senior Director, Regulatory Affairs
3 weeks ago
Senior Director, Regulatory Affairs Permanent San Francisco, CA Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinicalstage biotechnology company based in the San Francisco Bay Area, California. Primary Responsibilities In this role, you will lead global regulatory strategy and operations across the companys development pipeline. This individual will be responsible for developing and executing regulatory strategies, overseeing submission activities (INDs, CTAs, NDAs/BLAs/MAAs), and partnering with internal stakeholders and external agencies to advance programs through clinical development and regulatory review. The position is based in the San Francisco Bay Area, California in a hybrid work environment. Skills & Requirements Advanced degree (PhD, PharmD, MD, MS) or BS in a scientific discipline with 10+ years of regulatory affairs experience in the biotech/pharmaceutical industry, including 5+ years at the Director level or above. Demonstrated success developing and executing global regulatory strategies and leading submissions across multiple stages of drug development. Deep knowledge of US regulatory requirements (FDA), with experience in exUS markets (e.g., EMA, Health Canada, MHRA) preferred. Handson experience with INDs, CTAs, NDAs, BLAs, MAAs, and regulatory agency meeting preparations. Familiarity with special regulatory designations and accelerated pathways. Experience in a fastpaced biotech or small company environment; adaptable, proactive, and collaborative. Proficiency in regulatory operations, including working with publishing vendors and eCTD submissions. Experience with RIMS tools is a plus. Experience in immunology, dermatology, or rare diseases is a plus. The Senior Director, Regulatory Affairs will: Lead the development and execution of US and global regulatory strategies to support the advancement of their investigational products from preclinical through latestage development. Serve as the regulatory lead on crossfunctional project teams, providing regulatory guidance to ensure alignment with clinical, CMC, nonclinical, and corporate goals. Oversee preparation, submission, and maintenance of highquality regulatory documents (e.g., INDs, CTAs, amendments, briefing books, meeting requests, and responses to health authority queries). Manage interactions with regulatory authorities (FDA and exUS) including leading or supporting meeting preparation and correspondence. Evaluate regulatory risks and provide mitigation strategies to support timely development and approvals. Provide regulatory guidance on special designations (e.g., Orphan Drug, Fast Track, Breakthrough Therapy) and expedited pathways, as applicable. Support regulatory activities related to CMC, nonclinical, and pharmacovigilance to ensure comprehensive submission packages. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com . Proclinical Staffing is an equal opportunity employer. Seniority level Director Employment type Full-time Job function Science Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Proclinical Staffing by 2x Get notified about new Director of Regulatory Affairs jobs in San Francisco Bay Area . #J-18808-Ljbffr
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Senior Director, Regulatory Affairs
6 days ago
San Francisco, United States Proclinical Staffing Full timeSenior Director, Regulatory Affairs – Permanent – San Francisco, CA Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinical‑stage biotechnology company based in the San Francisco Bay Area, California. Primary Responsibilities In this role, you will lead global regulatory strategy and operations across the...
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Senior Director Regulatory Affairs Strategy
6 days ago
San Francisco, United States Precision Point Staffing ™ Full timeSenior Director Regulatory Affairs StrategyMy client is seeking a highly experienced and strategic Director or Senior Director of Regulatory Affairs to lead global regulatory strategies supporting product development and commercialization across key international markets, including the U.S., EU, Japan, Australia, and Canada.This individual will lead the...
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Senior Director Regulatory Affairs Strategy
2 weeks ago
San Francisco, CA, United States Precision Point Staffing Full timeSenior Director Regulatory Affairs Strategy My client is seeking a highly experienced and strategic Director or Senior Director of Regulatory Affairs to lead global regulatory strategies supporting product development and commercialization across key international markets, including the U.This individual will lead the Global Regulatory Team (GRT) and serve...
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Senior Director Regulatory Affairs Strategy
4 weeks ago
San Francisco, CA, United States Precision Point Staffing Full timeSenior Director Regulatory Affairs Strategy My client is seeking a highly experienced and strategic Director or Senior Director of Regulatory Affairs to lead global regulatory strategies supporting product development and commercialization across key international markets, including the U.S., EU, Japan, Australia, and Canada. This individual will lead the...
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Director Regulatory Affairs/Sciences
4 days ago
San Francisco, CA, United States BridgeBio Full timeDirector/Sr. Director Regulatory Affairs In 2015, we pioneered a moneyball for biotech approach, pooling projects and promising earlystage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements...
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Senior Director Regulatory Affairs
2 weeks ago
San Francisco, United States Vivid Resourcing Full timeDirector / Senior Director, Regulatory Affairs – Radiopharmaceuticals & ADC Oncology Location: San Francisco, CA (Hybrid 3 days/week) Remote considered for candidates with strong radiopharmaceutical or ADC backgroundCompensation Range: CompetitiveAbout the RoleA rapidly advancing oncology-focused biotech is developing next-generation targeted...
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San Francisco, CA, United States Valid8 Financial, Inc. Full timeDirector / Senior Director, Regulatory Affairs (Clinical & CMC) August 2025 Department: Regulatory For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to enable the development of our...
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San Francisco, CA, United States Valid8 Financial, Inc. Full timeDirector / Senior Director, Regulatory Affairs (Clinical & CMC) August 2025 Department: Regulatory Position Summary: The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to enable the development of our therapeutics. This individual will oversee both Clinical and CMC regulatory functions, providing...
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San Francisco, CA, United States Valid8 Financial, Inc. Full timeDirector / Senior Director, Regulatory Affairs (Clinical & CMC) August 2025 Department: Regulatory For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. Position Summary: The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to enable the...
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Senior Director, Global Regulatory Strategy Lead
2 weeks ago
San Francisco, CA, United States Olema Oncology Full timeSenior Director, Global Regulatory Strategy Lead - Regulatory Affairs Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our...
