Director, Clinical Regulatory — Global Regulatory Strategy Lead
Denali Therapeutics Inc.
A leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive development as a regulatory project lead. The role involves overseeing global Health Authority interactions, leading project teams, and developing regulatory strategies. An ideal candidate will have at least 10 years of experience in regulatory affairs, strong strategic skills, and the ability to mentor regulatory professionals. This position offers a competitive salary and comprehensive benefits package. #J-18808-Ljbffr Denali Therapeutics Inc.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Director, Clinical Regulatory — Global Regulatory Strategy Lead in South San Francisco, CA vacancy
- Kardigan in Princeton, NJ is seeking a Senior Director, Clinical Pharmacology to lead strategies across cardiovascular development and regulatory interactions with FDA and global health authorities. You will drive dose selection, exposure‑response analyses, PK/PD modeling...Suggested
- Nurix Therapeutics, based in Brisbane, CA, seeks a Director, Regulatory Affairs (Strategy, I&I) to lead global regulatory strategy for immunology and... ...submissions and lifecycle management in a fast-moving clinical development environment. You will oversee preparation...Suggested
- Enigma Search is looking for an Associate Director, Medical Writing in South San Francisco, California. This role involves leading the development of clinical and regulatory documentation, ensuring compliance with global standards, and managing the writing process. The...Suggested
- ...Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible... ...the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the... ...issues including Public Affairs, Clinical Development, Legal, and others...SuggestedLocal area
- Zai Lab Limited seeks a senior CMC regulatory leader to drive global regulatory strategy for both small molecules and biologics from its South San Francisco office. You will oversee IND/CTA and NDA/BLA submissions, coordinate with health authorities, and guide cross-functional...SuggestedWork at office
- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs...
- Denali Therapeutics Inc. seeks a senior regulatory affairs leader to develop and execute regulatory strategy for complex development programs in neurodegenerative diseases. You will drive interactions with global Health Authorities, manage submissions, and guide lifecycle...Remote job
$211k - $258.67k
...Denali is founded on the collaboration of leading scientists, industry experts, and... ...Responsibilities Developing and implementing regulatory strategy for complex development programs,... ...opportunities Overseeing and directly leading global Health Authority interactions,...Remote jobTemporary workWork experience placementLocal area- Genentech is looking for a PDQ Principal Quality Lead in South San Francisco, CA. This role requires a seasoned... ...professional to develop and execute quality strategies, manage audits, and ensure compliance with regulatory standards. Applicants should have at least 10 years...
- ...tactical medical leadership for global development programs, ensuring safety and regulatory compliance from early... ...launch. This executive will lead program teams across Clinical Development, Research and Translational... ...Commercial, set program strategy, and report to the Chief...
- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess a Master’s... ...therapies and ensuring clear communication with global health authorities. The candidate should be self-...
- Denali Therapeutics, located in South San Francisco, is looking for an experienced professional to develop regulatory strategies for complex programs. The role requires 10+ years of experience in regulatory affairs, leadership in cross-functional teams, and expertise in...
- ...Therapeutics, based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical execution for US and... ...and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years in drug development with...
- Lyell Immunopharma is seeking a Director of Regulatory Affairs/Global Regulatory Lead to define, develop, and execute global regulatory strategies for CAR-T programs from early development... ...FDA, EMA) and collaborate with CMC, Clinical Development, Translational Medicine,...
- Marea Therapeutics seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for the manufacturing of our products in the US and globally. The incumbent will oversee Regulatory CMC aspects of product...
- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies, ensuring compliance with health authority guidelines. The role requires collaboration with various teams, overseeing regulatory submissions...
- Zipline seeks a Director of Airspace Policy and Regulatory Affairs to shape how autonomous delivery integrates into global airspace. You will define policy strategy, engage with regulators, standards bodies, and industry peers, and translate regulatory changes into practical...
- Nurix Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. You will develop and execute the global regulatory strategy, guide high-quality submissions, and work with cross...
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities. This role reports to the Head of CMC Regulatory and is based in South San Francisco,...
- Kardigan, Inc. seeks a Senior Director, CMC Regulatory to lead regulatory activities for late-stage cardiovascular assets. You will define and execute CMC strategies, interact with global health authorities, and ensure timely, compliant submissions across programs. The...
- ...Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and... ...Controls (CMC) to shape regulatory strategies for manufacturing across the US and global markets. The role reports to... ...office. The candidate will lead CMC strategy, manage regulatory...Work at office2 days per week
- Marea Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for US and global manufacturing programs. This role reports to the Executive Director of Regulatory Affairs and requires...Full time
$218.06k - $327.09k
...you ready to set the global regulatory vision for pioneering... ...patients? This role leads high-impact programs... .... You will shape strategy for complex, visible... ...report to the Executive Director, Cell Therapy... ...regulatory objectives with clinical, CMC, safety and commercial...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$232k - $274k
...Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors... ...and executing the global regulatory strategy in... ...quality, nonclinical and clinical submissions and... ...functional development teams. Lead and manage the development...For contractorsWorldwide$220k - $254k
Director, Regulatory Affairs (Strategy, I&I) Brisbane, California, United States Director, Regulatory Affairs... ...(AID) Nurix Therapeutics is a clinical stage biopharmaceutical company... ...team and will serve as the global regulatory lead (GRL) for the immunology and inflation...For contractorsWork at office- AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) to lead regulatory strategy development and execution for US and Canada products. You will coordinate with FDA, support filings, and advise cross-functional teams on regulatory issues...
- ...States seeks an Associate Director of Clinical Pharmacology & MIDD to lead quantitative... ...making, coordinating with Regulatory Affairs, Translational Sciences... ...partners. The role emphasizes strategy development, study... ...interactions to support global development and lifecycle...
- Scorpion Therapeutics in South San Francisco, CA, seeks a Director of Regulatory Affairs / Global Regulatory Lead to craft and execute global regulatory strategies for CAR-T oncology products, lead cross-functional regulatory submissions, and manage agency interactions...
$150k - $250k
Ohalo is seeking a Global Crop Product Manager to coordinate go-to-market execution across Breeding, Sales, Channel Management, Regulatory, and Supply Chain from our South San Francisco, CA location... ...the commercial variety portfolio, lead cross-functional programs from...- ...Biosciences in South San Francisco seeks an Associate Director of Clinical Supply Chain to lead end-to-end CTM supply for multiple trials. You will coordinate... ...improvement across CMC, QA, Clin Dev/Clin Ops, Regulatory, and PM teams. Based onsite four days per week, you...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Clinical Regulatory — Global Regulatory Strategy Lead. Be the first to apply!
Related searches
- health insurance manager South San Francisco, CA
- director population health South San Francisco, CA
- health services director South San Francisco, CA
- senior director clinical development South San Francisco, CA
- hospital manager South San Francisco, CA
- medical operations supervisor South San Francisco, CA
- director environmental health & safety South San Francisco, CA
- medical and health service manager South San Francisco, CA
- healthcare data manager South San Francisco, CA
- occupational health manager South San Francisco, CA