Senior Director, Regulatory CMC — Hybrid (Biologics/MAbs)
Marea Therapeutics
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 and collaborates with Tech Ops leadership and external partners. This full‑time onsite position requires strategic thinking with hands‑on execution to drive CMC development and submissions, including device-related #J-18808-Ljbffr Marea Therapeutics
$275k - $280k
...lives! About the Job: The Senior Director of Regulatory CMC will lead the development... ...both small molecules and biologics, meticulous attention to detail... ...of small molecule and mAbs modalities. Exceptional communication... .... Are willing to work a hybrid or in person model with a...SeniorLocal areaRelocationRelocation package3 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 Affairs for biologics Bachelor’s Degree in biochemistry... ...monoclonal antibody (mAb) development is...SeniorFull timeWork at office2 days per week
$245k - $285k
...responsible for leading and managing the regulatory affairs within CMC function. This includes developing... ..., the position assists corporate senior management in understanding CMC Regulatory... ...and guidelines related to biologics drug development. Experience in the...SeniorContract work$258k - $320k
...employees. Job Description Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects across all phases of development, including strategy, dossier preparation and submissions...SeniorWork at officeWorldwideRelocation package$265k - $285k
...comResponsibilities include: Provides regulatory leadership in support of the... ...Operations, Medical Affairs, CMC, and Quality to develop,... ...ability to influence senior leadership and cross-functional... ...Experience supporting development of biologics and/or small molecules,...Senior$280k - $310k
...get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will... ...Authorities, and regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs.Effectively manages direct...SeniorLocal area- ...has offices in South San Francisco and San Diego, California. Reporting to the Chief Technical Officer, we are hiring a Director, CMC Regulatory Affairs to join our Technical Operations team. This role leads CMC regulatory activities and supports all of ORIC’s clinical...Senior
$275k - $280k
...increase our understanding of the biology that controls human aging.... ....Position Description:The Director of Regulatory CMC will lead the development... ...(NCEs) and Biologics (mAbs), including comparability protocols... ...stakeholders and senior leadership and externally 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 development...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 requires...SeniorFull time
$166k - $195k
...to courageously make the most complex biologics ever attempted to protect humankind.*LEAD... ....Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the... ...responsibilities, or changes to company policy): Hybrid (3 days per week onsite)Compensation:...Senior3 days per week- 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...SeniorWork at office2 days per week
$248k - $310k
...discoveries. These values are the foundation of our work, empowering us to make a real difference, every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To: Head of CMC Regulatory Location: South San Francisco, CA (onsite 4 days per...Senior- Kardigan is seeking a Senior Director, CMC Regulatory to lead regulatory strategies and interactions for late-stage programs focused on cardiovascular therapies. This role reports to the Head of CMC Regulatory and collaborates with cross-functional teams to align programs...Senior
- ...YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development... ...Lead (GRL), Associate Director, or Director), in the development... ...Bachelor's degree (pharmacy, biology, chemistry, pharmacology or...SeniorLocal area
- Meet Life Sciences is seeking a Senior Director of Regulatory CMC to lead global regulatory strategies for clinical development and commercial products... ...requires deep CMC expertise across small molecules and biologics, exceptional negotiation with authorities, and a track...
$175k - $205k
...and everything that we do on behalf of patients with cancer. Position Summary: Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will lead and participate in regulatory activities...SeniorTemporary workCasual workLocal areaWorldwideFlexible hours$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco, Californiatime... ...pioneering scientific innovations in muscle biology, and advancing a pipeline of... ...while managing multiple priorities #LI-HYBRID**Pay Range:**In the U.S., the hiring...SeniorFor contractors$143.07k - $162k
..., LinkedIn and Tik Tok . Job Description Senior Scientist 1, Bioassay Development, CMC Biologics, Analytical Research & Development, AbbVie Biotherapeutics... ....g. test methods, protocols, & reports) to enable regulatory submissions). Develop new techniques, explore...SeniorFull timeTemporary workWork experience placement- 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...
$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco... ...innovations in muscle biology, and advancing a pipeline... ...chain, CMC, quality, regulatory, program & portfolio management... ...modalities is desirable. #LI-HYBRID**Pay Range:**In the U.S.,...Senior- Corvus Pharmaceuticals, 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 NDA/MAA and lifecycle management. Reporting to the VP of Regulatory Affairs, the...
$218.06k - $327.09k
...Job Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation... ...regions, emerging markets, RA CMC, Labeling and members of the... ...standing experience of overall drug/biologic development processes and...SeniorHourly payTemporary workWorldwideFlexible hours3 days per week- ...compliant with global regulatory requirements and standards... ...to patients. The Senior Manager, Clinical Product... ...development teams (e.g., CMC teams), the Senior Manager... ...of the various R&D Directors and VP as well as external... ...in life sciences (biology, chemistry, or engineering...SeniorFull timeTemporary workLocal areaWorldwide
$147.8k - $320.2k
F. Hoffmann-La Roche AG is looking for a highly motivated Senior/Principal Machine Learning Scientist to join their Perturbation Biology group in South San Francisco. This role involves developing advanced machine learning models to enhance drug discovery processes. The...Senior- AbbVie is seeking a Senior Scientist 1 in Bioassay Development, CMC Biologics, Analytical Research & Development, to advance bioassays and potency methods for complex biotherapeutics in South San Francisco, onsite 5 days a week. The role requires an MS in biology/biochemistry...Senior
$150k - $170k
...a talented, motivated Senior Manager to join our Portfolio... ...Technology, Clinical, Regulatory, and other development... ...with an emphasis on CMC knowledge and the ability... ...plans. This is a hybrid role based at our headquarters... ...; experience with biologics or complex modalities is...SeniorFull timeWork at officeLocal areaRemote work$180k - $210.5k
...to courageously make the most complex biologics ever attempted to protect humankind.*LEAD... ...and executes multi-product global regulatory CMC strategies for investigational products... ...and ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos, CA...- ...organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory team... ...report directly to the Director of Regulatory Affairs and... ...discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences,... ...regulatory leadership. Hybrid or onsite working model available...
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