Global CMC Regulatory Strategy Director
ACADIA Pharmaceuticals Inc.
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 including GCC, LATAM, and APAC. You will serve as the CMC expert on cross-functional teams, guide interactions with authorities, and drive lifecycle activities while managing a team and ensuring timely submissions. #J-18808-Ljbffr ACADIA Pharmaceuticals Inc.
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- 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...
- ...located in Brisbane, California, seeks a Senior Director of Regulatory Affairs to lead global regulatory strategies for the Annexon portfolio. You will guide regulatory... ...FDA and EMA, while coordinating with Clinical, CMC, and Quality teams. You will mentor regulatory staff...
- 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...
- Corvus Pharmaceuticals, a clinical-stage biopharma company, seeks a Director of Regulatory Affairs CMC to develop global CMC strategies for small molecules and lead regulatory submissions. This role partners with CMC, Technical Operations, Quality, and Clinical teams to...
$220k - $270k
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The... ...various departments to ensure compliance with CMC regulatory strategies for oncology products. The anticipated salary range is...- A growing biotechnology company in San Francisco is seeking a Senior Director, Regulatory Affairs to lead their global regulatory strategy and oversee submission activities. The position requires over 10 years of regulatory affairs experience, including 5 years at the director...
- Marea 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 the Executive Director of Regulatory Affairs and will own CMC...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
- 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-...
- ...Medicines in San Francisco is looking for an Associate Director, CMC Regulatory to lead the execution of regulatory strategies for clinical development and lifecycle... ...collaboration with various teams to ensure compliance with global regulatory requirements. The ideal candidate...
- A leading biopharmaceutical company in South San Francisco seeks a Director of Regulatory CMC. This pivotal role involves developing global regulatory strategies for a pipeline of small molecules and monoclonal antibodies, ensuring compliance throughout the product lifecycle...
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- Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role requires strong regulatory knowledge, organizational skills, and the ability to lead cross-functional projects. Candidates should...
- 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...
- Corvus Pharmaceutical, a clinical-stage biopharmaceutical company, is seeking a Director of Regulatory Affairs CMC reporting to the VP of Regulatory Affairs to lead global CMC regulatory strategies for clinical-stage small molecule programs. This role partners with CMC,...
- Nurix Therapeutics, Inc. is seeking a Director/ Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to develop and execute global regulatory strategy and lead high-quality submissions. You will partner with SVP Regulatory Affairs and cross-functional...
$275k - $280k
...exciting place to catalyze and enable medical breakthroughs.Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate...- AstraZeneca in the United States is seeking a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial (CTSC). You will lead end... ...across indication-level portfolios, collaborate with global and TA teams, and shape PH3ID forecasts with industry-leading...
$245k - $285k
...candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The successful candidate will ensure that all...Contract work$258k - $320k
...our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage... ...Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects...Work at officeWorldwideRelocation package$220k - $270k
Senior Director/ Director, CMC Regulatory Affairs ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving... ...Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC...Currently hiring- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials.... ...documents, ensuring regulatory compliance, and coordinating global submissions. The ideal candidate will have 5+ years in...Remote job
- ...We are seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for the development of regulatory strategies and submissions related to the... ...manufacturing of our products in the US and globally. The incumbent will be...Full timeWork at office2 days per week
- Marea Therapeutics in South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies for manufacturing products in the US and globally. The role reports to the Executive Director, Regulatory Affairs...Full time
- Nurix Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team in Brisbane, CA. This global lead role develops regulatory strategy for immunology and inflammation, guiding early development and lifecycle management, with cross...
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