Global CMC Regulatory Strategy Director
Zai-Lab-
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 teams across development stages. The role requires strong leadership, deep CMC knowledge, and fluency in English and Chinese, with a track record of successful global submissions and regulatory interactions. #J-18808-Ljbffr Zai-Lab-
- 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...Suggested
- Meet Life Sciences is seeking a Senior Director of Regulatory CMC to lead global regulatory strategies for clinical development and commercial products. The role requires deep CMC expertise across small molecules and biologics, exceptional negotiation with authorities,...Suggested
- Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory strategies for small molecule therapies from development through commercialization worldwide. In this leadership role, you will guide CMC submissions, regulatory interactions, and lifecycle...SuggestedWorldwide
- 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...Suggested
- 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...SuggestedFull time
- 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 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
- 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...
- 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-...
- 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...
- 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...
- 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...
$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...$189.7k - $237.1k
...week on average Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small... ...this leadership position, you will develop and execute global regulatory CMC strategies that support clinical development, marketing...Work at officeLocal areaRemote workWorldwideNight shift3 days per week$260k - $295k
...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 officeLocal area2 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
$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$248k - $310k
..., every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports... ...who will help define CMC Regulatory strategies and successfully execute them in submissions... ...to ensure on-time delivery of global, high-quality submissions across all...$275k - $280k
...allowing people to live longer, healthier, and happier lives! About the Job: The Senior Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies to accelerate clinical development and ensure seamless commercialization. This role...Local areaRelocationRelocation package3 days per week- 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... ...authorities (FDA, EMA) and collaborate with CMC, Clinical Development, Translational...
$210k - $260k
ORIC Pharmaceuticals is seeking an Associate Director, CMC Project Management to lead the strategic direction of CMC activities. This role... ...on ensuring excellence in development, manufacturing, and regulatory compliance while managing budgets effectively. The successful...- ...prominent healthcare systems, governments, retailers, restaurants and global businesses who rely on us to save lives, reduce emissions,... ...Does the opportunity to architect and lead the global sourcing strategy for one of the world’s most innovative robotics companies sound...Long term contractContract workLocal areaWorldwide
$280k - $310k
...seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader... ...implementation of all regulatory CMC strategies to support market applications, post-marketing CMC commitments, and global development programs across Mirum...Local area- 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...
$157.59k - $203.94k
...together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device is responsible... ...This role supports the development and implementation of global regulatory strategy and is accountable for execution of high-quality...Full timeFor contractorsLocal area$210.38k - $272.25k
...Join Gilead and help create possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex, high-impact device and combination product portfolios...Full timeFor contractorsLocal area- Kardigan, Inc. is seeking a Senior Director of Intellectual Property to provide strategic IP counsel across programs, reporting to the Vice President of Intellectual Property. The role will lead patent protection efforts and coordinate with multiple teams in a hybrid setup...
- ...Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development... ...the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the...Local area
- ...partnering with a well-established global pharmaceutical and... ...organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory... ...hands-on role in regulatory strategy and submissions,... ...will report directly to the Director of Regulatory Affairs and...
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