Senior Director Regulatory Affairs
2 weeks 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 backgroundCompensation Range: CompetitiveAbout the RoleA 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 DoLead regulatory strategy for radiopharmaceutical and ADC programs entering early clinical developmentDrive preparation, authorship, and submission of INDs—including Module 2 and scientific content across CMC, nonclinical, and clinical sectionsServe as primary FDA point of contact, managing meeting requests, briefing documents, and regulatory negotiationsProvide strategic guidance across cross-functional teams (R&D, CMC, Clinical, Program Strategy) on regulatory expectations for complex oncology modalitiesSupport development of regulatory roadmaps for first-in-class radiopharmaceutical and ADC assetsLead preparation and management of IND amendments, annual reports, and safety updatesMonitor evolving global regulations impacting radiopharma, oncology, and next-gen ADC developmentContribute to internal best practices, submission planning, and RA operational excellenceQualificationsBachelor’s degree in a scientific discipline; advanced degree (MS, PharmD, PhD) preferred7–10+ years of biotech/pharma industry experience, with at least 5+ in Regulatory AffairsStrong experience preparing early-phase INDs (required)Background in radiopharmaceuticals, oncology, nuclear medicine, or targeted radiation highly preferredExperience supporting complex modalities such as ADCs, radio-conjugates, or biologics strongly valuedSolid understanding of clinical pharmacology, trial design, and nonclinical requirements for oncology INDsExcellent communication skills with the ability to influence across R&D, clinical, and executive teamsDemonstrated ability to lead submissions in fast-paced, growing, or early-stage environmentsHighly organized, solutions-oriented, and proactive in anticipating regulatory needsWhat You’ll ReceiveCompetitive base salary + performance bonus + equityMedical, dental, vision, and disability coverageGenerous PTO, sick time, and paid holidaysHybrid work environment with flexibility for highly qualified remote candidatesA mission-driven culture grounded in scientific excellence, collaboration, and patient impactWhy This Role MattersYou'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
2 weeks ago
Hayward, CA, 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 background With multiple programs approaching key regulatory milestones, the company is seeking an accomplished Regulatory Affairs leader to...
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Account Director | Public Affairs
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Hayward, United States Keadjian Full timeAccount Director | San Francisco Bay Area | Hybrid WorkPublic Affairs | Corporate CommunicationsEnergy | Land Use | InfrastructureKeadjian Associates, a leading strategic communications and management consulting firm in the San Francisco Bay Area, is seeking a full-time account director to begin work immediately. The candidate should possess at least five to...
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Hayward, United States Oakmont Senior Living Full timeArea Business Development Director Ideal candidate will be located in the San Jose market. Salary range: $95,000-$105,000 plus a bonus structure. Schedule: Tuesday – Saturday Senior Living experience required! The Business Development Director is responsible for generating and managing leads and developing relationships with referral partners that will...
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Hayward, United States WestWater Research Full timeWater Consulting Senior Associate Position Summary WestWater Research seeks a Water Consulting Senior Associate to support and lead water resource initiatives in California. This role focuses on water supply planning, transaction advisory, and valuation projects, with a strong emphasis on the economic, legal, and regulatory aspects of western water markets....
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Hayward, United States PowerBack Rehabilitation Full timeOverview At Powerback, we're on a mission to improve lives. As the leader in physical, occupational, speech, and respiratory therapies, we help older adults stay active and thrive while providing essential therapy for children at home and in school. With over 38 years of trusted service, our reach spans skilled nursing centers, assisted and independent...
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