Senior Director Regulatory Affairs
1 week ago
Director / Senior Director, Regulatory Affairs – Radiopharmaceuticals & ADC Oncology Location: San Francisco, CA (Hybrid 3 days/week) Remote considered for candidates with strong radiopharmaceutical or ADC background Compensation Range: Competitive About the Role A rapidly advancing oncology-focused biotech is developing next-generation targeted therapies—including radiopharmaceuticals and early-stage antibody–drug conjugates designed for precise tumor targeting. With multiple programs approaching key regulatory milestones, the company is seeking an accomplished Regulatory Affairs leader to guide early clinical development strategy and drive the IND process for complex oncology therapeutics. This is a high-impact opportunity for someone passionate about shaping first-in-human development in one of the most innovative areas of cancer therapy. What You'll Do Lead regulatory strategy for radiopharmaceutical and ADC programs entering early clinical development Drive preparation, authorship, and submission of INDs—including Module 2 and scientific content across CMC, nonclinical, and clinical sections Serve as primary FDA point of contact, managing meeting requests, briefing documents, and regulatory negotiations Provide strategic guidance across cross-functional teams (R&D, CMC, Clinical, Program Strategy) on regulatory expectations for complex oncology modalities Support development of regulatory roadmaps for first-in-class radiopharmaceutical and ADC assets Lead preparation and management of IND amendments, annual reports, and safety updates Monitor evolving global regulations impacting radiopharma, oncology, and next-gen ADC development Contribute to internal best practices, submission planning, and RA operational excellence Qualifications Bachelor's degree in a scientific discipline; advanced degree (MS, PharmD, PhD) preferred 7–10+ years of biotech/pharma industry experience, with at least 5+ in Regulatory Affairs Strong experience preparing early-phase INDs (required) Background in radiopharmaceuticals, oncology, nuclear medicine, or targeted radiation highly preferred Experience supporting complex modalities such as ADCs, radio-conjugates, or biologics strongly valued Solid understanding of clinical pharmacology, trial design, and nonclinical requirements for oncology INDs Excellent communication skills with the ability to influence across R&D, clinical, and executive teams Demonstrated ability to lead submissions in fast-paced, growing, or early-stage environments Highly organized, solutions-oriented, and proactive in anticipating regulatory needs What You'll Receive Competitive base salary + performance bonus + equity Medical, dental, vision, and disability coverage Generous PTO, sick time, and paid holidays Hybrid work environment with flexibility for highly qualified remote candidates A mission-driven culture grounded in scientific excellence, collaboration, and patient impact Why This Role Matters You'll play a central role in advancing first-in-human radiopharmaceutical and ADC programs designed to address aggressive cancers with limited therapeutic options. If you're driven by building INDs from the ground up and enjoy shaping regulatory frameworks for emerging oncology modalities, this position offers both challenge and meaningful impact.
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Director/Senior Director Regulatory Affairs
4 days ago
South San Francisco, CA, United States Scientific Search Full timeSenior Director, Global Regulatory Lead Base Salary : $270-285k range plus bonus and RSU’s Hybrid Onsite – Relocation Offered. Remote candidates will not be considered. Scientific Search has recently partnered with a commercial stage pharmaceutical company that is looking for a Senior Director, Global Regulatory Lead. This role is accountable for...
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Senior Director, Regulatory Affairs
3 weeks 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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Director/Senior Director Regulatory Affairs
5 days ago
South San Francisco, CA, United States Scientific Search Full timeSenior Director, Global Regulatory Lead Considering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out. Base Salary : $270-285k range plus bonus and RSU’s Hybrid Onsite – Relocation Offered. Remote candidates will not be considered. Scientific Search has recently partnered with a...
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Senior Director Regulatory Affairs
2 weeks ago
South San Francisco, CA, United States Scientific Search Full timeSenior Director, Global Regulatory Lead Location: South San Francisco, CA Base Salary : $270-285k range plus bonus and RSU’s Hybrid Onsite – Relocation Offered. Remote candidates will not be considered. Scientific Search has recently partnered with a commercial stage pharmaceutical company that is looking for a Senior Director, Global Regulatory Lead....
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Senior Director Regulatory Affairs
1 week ago
South San Francisco, CA, United States Scientific Search Full timeSenior Director, Global Regulatory Lead Location: South San Francisco, CA Base Salary: $270-285k range plus bonus and RSU's Hybrid Onsite – Relocation Offered. Remote candidates will not be considered. Scientific Search has recently partnered with a commercial stage pharmaceutical company that is looking for a Senior Director, Global Regulatory Lead. This...
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Senior Director Regulatory Affairs Strategy
3 weeks 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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Director Regulatory Affairs/Sciences
3 weeks 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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San Diego, United States Rakuten Medical Full timeDirector/Senior Director of Global Regulatory Affairs Director/Senior Director of Global Regulatory Affairs – Rakuten Medical Company Profile Rakuten Medical, Inc. is a global biotechnology company developing precision, cell‑targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads...
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Senior Director, Global Regulatory Strategy Lead
4 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...
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Director – Regulatory
3 weeks ago
San Jose, United States OptraSCAN Full timeDirector – Regulatory & Clinical Affairs (USA) OptraSCAN is a global leader in digital pathology and precision medicine solutions, specializing in whole-slide imaging systems, AI‑driven analytics, and cloud‑enabled telepathology platforms. With customers across the US, Europe, and Asia, OptraSCAN is transforming disease diagnostics through...
