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.
- Kardigan is seeking a Senior Director, CMC Regulatory to lead regulatory strategies and interactions for late-stage programs focused on cardiovascular therapies... ...with FDA, EMA, and ICH guidelines, plus a track record of successful global #J-18808-Ljbffr Socket.devSuggested
- ...San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs... ...collaborate with regulatory, quality, clinical, and manufacturing teams to... ...strategies and prepare global submissions. The role requires...Suggested
$240.94k - $291.96k
...Expected Areas of Competence Develop and lead Global and US Regulatory activities for a Development Team (s)... ...stakeholders Develop registration strategy for a product, and translate that... ...documents and study reports, including Clinical protocols, clinical reports/summary documents...SuggestedLocal area- Enigma Search is seeking a seasoned Director of Regulatory Affairs to shape regulatory strategy for innovative programs. You will lead global submissions, interact with health authorities, and partner with executive leadership to align regulatory plans with corporate aims...Suggested
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- ...Inc. in South San Francisco, CA, is seeking a Director of Regulatory Affairs CMC to lead global regulatory strategies for small molecule programs from IND/CTA through... ...Affairs, the role collaborates with CMC, Quality, Clinical and Operations to ensure timely, compliant...
- 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...
- Zai Lab is seeking an Associate Director, Regulatory Affairs in South San Francisco, CA to lead regulatory strategy and execution for clinical programs across regions. This role collaborates... ...on development documents, and monitor global regulatory developments while...
- ACADIA Pharmaceuticals Inc. seeks a Director, Regulatory CMC to lead global regulatory CMC strategies for small molecule programs from development through commercialization. You will advance development, regulatory submissions, and lifecycle management across key regions...
- Zai Lab is seeking a global CMC regulatory leader to head regulatory strategy for small molecules and biologics across all development stages. You will oversee submissions... ...ensuring compliance and scientific rigor. You will lead a team of CMC professionals, collaborate with QA/QC,...Worldwide
- VetJobs in Princeton, New Jersey, is seeking a regulatory affairs leader to develop and manage Global and US regulatory activities for Development Teams. You... ...issues in plans. You will formulate US regulatory strategy, lead global submissions, and provide input on target...
- ...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...
- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs.... ...partner with Regulatory Affairs, Quality, and Clinical teams to ensure compliant INDs, CTAs, NDAs,...
- ...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...Local area
- Scorpion Therapeutics is seeking a Director, Regulatory CMC to lead global CMC strategies across clinical development, approvals, and lifecycle management. You will guide cross-functional teams, interface with agencies, and ensure compliance with regulatory requirements...
- 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
$220k - $270k
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The ideal candidate... ...to ensure compliance with CMC regulatory strategies for oncology products. The anticipated salary range...$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...
- 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...
- 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,...
- ...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...
- 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...
$215.54k - $260.82k
Associate Director, Clinical Regulatory page is loaded## Associate Director, Clinical... ...on the collaboration of leading scientists, industry experts... ...expertise. This individual is a Global Regulatory Leader... ...for developing regulatory strategy for complex development programs...Work experience placementLocal area- 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...
- 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...
- 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,...
- 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
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