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
- ...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
- Kardigan, Inc. seeks a Senior Director, CMC Regulatory to lead regulatory activities for late-stage cardiovascular assets... ...and execute CMC strategies, interact with global health authorities, and ensure timely, compliant submissions across programs. The ideal candidate has 1...Senior
- 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,...Senior
- 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
$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$248k - $310k
...difference, every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs... ...strategies and successfully execute them in submissions and health authority interactions,... ...to ensure on-time delivery of global, high-quality submissions across all...Senior- ...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- 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
- 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...Work at office
$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- 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
- ...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
$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$270k - $295k
...experienced and highly motivated Senior Director of Regulatory Affairs to lead regulatory... ...regulatory plans and submissions to support preclinical and... ...submissions, and interactions with global health authorities. The... ...meetings. Partner with CMC, Nonclinical, and Clinical...SeniorFull time- ...Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors)... ...Regulatory team. You will develop and execute the global regulatory strategy, guide high-quality submissions, and work with cross-functional partners to...Senior
$218.06k - $327.09k
...Job Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development... ...implementation of the global regulatory strategy for... ...stage through BLA submission. May serve in dual-role... ..., emerging markets, RA CMC, Labeling and members...SeniorHourly payTemporary workWorldwideFlexible hours3 days per week- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies... ...requires collaboration with various teams, overseeing regulatory submissions, and guiding development programs. The ideal candidate will...
- Nurix Therapeutics, based in Brisbane, CA, seeks a Director, Regulatory Affairs (Strategy, I&I) to lead global regulatory strategy for immunology and... ...and Health Authorities to enable timely regulatory submissions and lifecycle management in a fast-moving clinical...
- Denali Therapeutics Inc. seeks a senior regulatory affairs leader to develop and execute regulatory strategy for complex... ...neurodegenerative diseases. You will drive interactions with global Health Authorities, manage submissions, and guide lifecycle management across programs....SeniorRemote job
- Kardigan in Princeton, NJ is seeking a Senior Director, Clinical Pharmacology to lead... ...cardiovascular development and regulatory interactions with FDA and global health authorities. You will... ...Medical Writing to ensure successful submissions and program execution. #J-18808-...Senior
$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco, Californiatime... ...interactions, including original REMS submissions, assessments, modifications, and... ...practices# REMS Design & Governance* Own global oversight of REMS design, including Elements...SeniorFor contractors- ...oversee project management of drug development processes. Responsibilities include leading cross-functional teams, managing regulatory submissions, and ensuring projects meet business needs. Ideal candidates will possess strong leadership, project management skills, and...Senior
- Lyell Immunopharma is seeking a Director of Regulatory Affairs/Global Regulatory Lead to define, develop, and execute global regulatory strategies for CAR... ...health authorities (FDA, EMA) and collaborate with CMC, Clinical Development, Translational Medicine, and Medical...
$166k - $195k
...communications and decision making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company’s project... ...the planning, coordination, and execution of regulatory CMC submissions — including BLAs and Prior Approval Supplements — while...Senior3 days per week- ...Pharmaceuticals Inc. in South San Francisco is seeking an Associate Director of CMC Program Management to lead end-to-end CMC strategies, cross-... ...acumen, and ability to navigate complex programs across regulatory and commercial #J-18808-Ljbffr ORIC Pharmaceuticals Inc.Senior
$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$180k - $195k
...every member, from interns to senior leaders. Our environment is dynamic... ...The Role Reporting to the Director, Regulatory Affairs, the Senior Manager,... ...coordination, preparation, and timely submission of regulatory documents and filings Review global regulatory submissions for...SeniorFull timeFor contractorsLocal area3 days per week- 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...
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