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
Vacancy posted 18 hours ago
Similar jobs that could be interesting for youBased on the Senior Director, Regulatory CMC — Hybrid (Biologics/MAbs) in South San Francisco, CA vacancy
- ...Therapeutics, based in South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions... ...high‑quality CTA/IND and BLA/MAA filings for biologics, manage the CMC document control system, and...Senior
- ...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$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$140k - $214k
...Position Summary:Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast-paced and... ...Manager will report to the Senior Director of Regulatory CMC and will be responsible... ...experience in CMC development of biologics preferred.Experience with a...SeniorContract workFor contractorsFlexible hours$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...- ...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
$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, 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
- 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
- ...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
- ...contributions can directly advance novel therapies for patients with cancer Position: Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs, CMC, will serve as the lead CMC regulatory expert supporting products in clinical development....Senior
$175k - $205k
Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote Erascais a clinical-stage precision oncology... ...to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will...SeniorTemporary workCasual workLocal areaRemote workWorldwideFlexible hours$285k - $320k
...improve clarity, speed, and quality of work. What You'll Do Lead CMC regulatory strategy and execution across development and post‑approval... ...mental health support (therapy and coaching resources) Hybrid work model with flexibility Flexible, “take‑what‑you‑need” paid...SeniorWork at officeRemote workFlexible hours- ...BridgeBio is seeking a Senior Manager, Project Management in San Francisco. This hybrid role involves organizing CMC/QA team activities, managing manufacturing activities with CDMOs, and ensuring adherence to team goals. The ideal candidate has a strong project management...Senior
BridgeBio
San Francisco, CA1 day ago - 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
$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- Johnson & Johnson Innovative Medicine is recruiting a Senior Director External Innovation, DPDS (Biologics Modality Focused) located in San Francisco or San Diego. The role leads external partnerships, scouting opportunities, and guiding evaluations within DPDS for biologic...Senior
- ...well-established global pharmaceutical company is seeking a Regulatory Affairs Manager CMC for its San Francisco team. This role involves developing... ...processes while working with experienced leadership. A hybrid or onsite working model is available, making it an exciting...
- 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...
$188k - $215k
...clarity, speed, and quality of work. What You’ll Do Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC Regulatory... ...or control strategies. Where You’ll Work This is a hybrid role and preference will be given to candidates local...SeniorFull timeWork at officeLocal areaRemote workFlexible hours- ...applicants for employment. Position: Senior Manager / Associate Director, Regulatory Affairs Location: South San... ...This role spans both Clinical and CMC (Chemistry, Manufacturing, and Controls... ...Education: PhD in Neuroscience, Cell Biology, Biochemistry, or a related...SeniorWork at officeShift work
$195.5k - $272.5k
...motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned... ...and/or commercial large molecules (biologics) is required experience with... ...plusAbility to effectively present to Senior Management#LI-AS1#LI-OnsiteWHO WE ARE...Full timeWork at officeWork visa3 days per week- Senior Principal Data Scientist (Healthcare & Life Sciences) South San Francisco, CA - Hybrid Duration: Long term Senior Principal Data Scientist... ...that transform complex biological, clinical, and real-world... ...clinical trial design, regulatory submissions, and the delivery...SeniorWork at office
- ...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
AbbVie Inc.
South San Francisco, CAa month ago $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- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role involves preparing CMC documents, ensuring regulatory compliance, and coordinating global submissions. The ideal candidate...SeniorRemote job
$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...SeniorWork at officeLocal areaRemote workAllogene Therapeutics
South San Francisco, CA3 days ago- Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory... ...10+ years in regulatory, with extensive experience in biologics and gene/cell therapy. Some travel (approx. 20%) is...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Regulatory CMC — Hybrid (Biologics/MAbs). Be the first to apply!
Related searches
- associate director compliance South San Francisco, CA
- director global regulatory affairs South San Francisco, CA
- senior director regulatory affairs South San Francisco, CA
- regulatory cmc manager South San Francisco, CA
- regulatory affairs manager pharmaceutical South San Francisco, CA
- healthcare compliance manager South San Francisco, CA
- regulatory manager South San Francisco, CA
- manager regulatory affairs South San Francisco, CA
- regulatory & compliance manager South San Francisco, CA
- head compliance South San Francisco, CA