Senior Director, Regulatory CMC — Global Submissions
BioSpace
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 development, manufacturing, and eventual commercialization. The role combines strategic thinking with hands-on execution and requires collaboration with internal and external cross-functional teams. #J-18808-Ljbffr BioSpace
- 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...Senior
- ...Chief Technical Officer, we are hiring a Director, CMC Regulatory Affairs to join our Technical... ...regulatory strategies in compliance with global regulatory requirements for the development... ...manage all CMC aspects of regulatory submissions, including strategy for updating...Senior
- ...South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory... ...manufacturing products in the US and globally. The role reports to the... ...to drive CMC development and submissions, including device-related #J...SeniorFull time
- 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...SeniorFull time
- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory... ...manufacturing across the US and global markets. The role reports to... ...Regulatory Affairs and will own CMC submissions and alignment with Tech Ops....SeniorWork at office2 days per week
- ...member, from interns to senior leaders. Our... ...seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for... ...regulatory strategies and submissions related to the... ...products in the US and globally. The incumbent will be...SeniorFull timeWork at office2 days per week
$245k - $285k
...leading and managing the regulatory affairs within CMC function. This includes developing... ...cell therapy product on a global basis. The successful... ...assists corporate senior management in understanding... ...all types of regulatory CMC submissions including type B, C, D meetings...SeniorContract work$258k - $320k
...has secured partnerships with leading global biopharmaceutical companies, generating... ...Responsible for leading the global CMC regulatory strategy and execution for both small molecule... ...strategy, dossier preparation and submissions, and responses to the regulatory agencies...SeniorWork at officeWorldwideRelocation package$280k - $310k
...fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader... ...be responsible for all CMC-related submissions: strategic planning, execution, and... ...-marketing CMC commitments, and global development programs across Mirum portfolio...SeniorLocal area- Marea Therapeutics, based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical... ...coordinating with internal teams and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years...Senior
$175k - $205k
...Summary Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of... ...regulatory support through QC review of submission components, including CMC... ...support development of appropriate global regulatory filing strategies. Collaborate...SeniorTemporary workCasual workLocal areaWorldwideFlexible hours- 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...Senior
$275k - $280k
...interventions 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...SeniorLocal areaRelocationRelocation package3 days per week$140k - $214k
Position Summary Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast‑... ...will report to the Senior Director of Regulatory CMC and will be... ...to lead and support regulatory submissions and activities in the US and globally to support development programs...SeniorFlexible hours- ACADIA Pharmaceuticals Inc. seeks a Director, Regulatory CMC to lead global regulatory CMC strategies for small molecule programs from development through... .... You will advance development, regulatory submissions, and lifecycle management across key regions including...
- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology... ...drive preparation of Module 2/3, IMPD, and post-submission activities, manage timelines, and mentor a regulatory...
- 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 (IND/CTA, NDA/BLA/MAA) and manage end-to-end dossier preparation, ensuring compliance and scientific...Worldwide
- Meet Life Sciences is seeking a Senior Director of Regulatory CMC to lead global regulatory strategies for clinical development and commercial products.... ...with authorities, and a track record of successful submissions. The candidate will manage CTD modules and data packages...
$244k - $305k
...signaling pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute... ...cross-functional teams. Regulatory Submission Leadership Provide strategic oversight... ...Development, Biometrics, and CMC to deliver high-quality global submissions...SeniorFull timeLocal area- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials... ..., ensuring regulatory compliance, and coordinating global submissions. The ideal candidate will have 5+ years in biotech/pharma...SeniorRemote job
$275k - $280k
...Position Description : The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for... ...post-approval supplements Submissions and Document Leadership... ...-functional stakeholders and senior leadership and externally with...- ...XandYouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid)... ...Regulatory Lead (GRL), Associate Director, or Director), in the development... ...preparation and review of regulatory submissions consistent within US and Canada regulatory...Senior
- ...and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid)... ...Regulatory Lead (GRL), Associate Director, or Director), in the development... ...preparation and review of regulatory submissions consistent within US and Canada regulatory...SeniorLocal area
$265k - $285k
...comResponsibilities include: Provides regulatory leadership in support of... ..., Medical Affairs, CMC, and Quality to develop,... ..., and implement global regulatory strategies and submissions, including CTAs, for new... ...activitiesProven ability to influence senior leadership and cross-...Senior- 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...
$157.59k - $203.94k
...together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and... ...development and implementation of global regulatory strategy and is... ...execution of high-quality regulatory submissions and lifecycle activities that support...SeniorFull timeFor contractorsLocal area- BridgeBio seeks a Senior Manager / Associate Director, CMC Regulatory Sciences in the San Francisco area for a hybrid role.... ...strategies, author and review regulatory submissions, and respond to health authority queries to support global filings. You will drive strategies...Senior
- The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) leads initiatives to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs and amendments. This role builds relationships across Regulatory Affairs, Operations...Senior
$188k - $215k
...quality of work. What You’ll Do Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC... ...and drug product sections of global clinical trial applications and supplements... ..., and consistency of regulatory submissions while adhering to company...SeniorFull timeWork at officeLocal areaRemote workFlexible hours- ...Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across... ...manufacturing teams to develop regulatory strategies and prepare global submissions. The role requires strong scientific writing, experience...
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