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
$260k - $295k
...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 officeLocal area2 days per week$230k - $270k
...Therapeutics is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory... ...and high quality. The position is a hybrid role located in South San Francisco... ...Practices (GMP), drug and biologics development regulations and guidelines...SeniorFull timeContract workInternshipLocal areaRemote work2 days per week$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$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
- 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- ...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
$143.07k - $162k
...Instagram, YouTube, LinkedIn and Tik Tok. Job Description Senior Scientist 1, Bioassay Development, CMC Biologics, Analytical Research & Development, AbbVie... ....g. test methods, protocols, & reports) to enable regulatory submissions). Develop new techniques, explore new...SeniorTemporary workWork experience placement$270k - $295k
...Septerna is seeking an experienced and highly motivated Senior Director of Regulatory Affairs to lead regulatory strategy and execution across our... ...coordinate and prepare for regulatory meetings. Partner with CMC, Nonclinical, and Clinical teams to ensure compliance with...SeniorFull time- 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
$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
$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...- 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
$157.59k - $203.94k
...empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device is responsible for supporting CMC regulatory activities for development or...SeniorFull timeFor contractorsLocal area$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$65 - $75 per hour
...seeking a highly motivated Senior Scientist, Computational Biology to join our team. The... ...translational, clinical, and regulatory work — from multi-platform... ...in South San Francisco, CA hybrid onsite 3 days a week or remote... ...Regulatory and CMC support Generate analysis...SeniorHourly payTemporary workFor contractorsInternshipLocal areaRemote work3 days per week- ...milestones, we are seeking a Senior Director of Quality Systems and... ...ensure compliance with global regulatory standards. You will provide... ...making. Qualifications B.S. in Biological Sciences, Chemistry,... ...for patients. #LI-KD1 #LI-Hybrid #J-18808-Ljbffr Allogene TherapeuticsSeniorWork at officeLocal areaRemote work2 days per week
$147.8k - $274.4k
...medicines for patients worldwide.The OpportunityWe are seeking a highly motivated and collaborative Senior/Principal Machine Learning Scientist to join the Perturbation Biology group in the Department of AI for Biology & Translation (AIBT) in Genentech Research and Early...SeniorFull timeLocal areaWorldwide- NOETIK is seeking a Senior Scientist to drive hands-on spatial biology experiments on human tissue samples, with a focus on in situ hybridization and proteomics, while contributing to AI model training data. The role emphasizes rigorous data quality, protocol development...Senior
$275k - $280k
...increase our understanding of the biology that controls human aging.... ...: Calico is seeking a Regulatory Director that will be responsible for... ...Leadership, Clinical Development, CMC, and Commercial teams... ...communicating key updates to senior leadership and project teams...Full time$210.38k - $272.25k
...Gilead and help create possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and Device is responsible... ...productsDemonstrated success influencing strategy and decision-making across senior cross-functional stakeholders in complex, matrixed...Full timeFor contractorsLocal area- Vaxart is seeking a Senior Director, Quality Assurance to lead QA for clinical-stage oral tablet... ...across GMP manufacturing, testing, and CMC activities, with a focus on risk-based... ...collaboration with CMC, Operations, Regulatory, and external labs. Reporting to the CTO...Senior
- ...Therapeutics is seeking an experienced Senior Director, Quality Control to join the Analytical... ...infrastructure, and a team to support programs from CMC development through commercial... ...small-molecule QC expertise, strong regulatory acumen, and a track record managing...Senior
- Merck is seeking a Senior Scientist to join the Respiratory Biology Discovery group. The role focuses on target identification, validation, translational biology, and mechanism-of-action studies for chronic lung diseases, using primary airway/alveolar epithelial biology...Senior
- MSD is seeking a Senior Scientist to join the Respiratory Biology Discovery group, driving target identification, validation, translational biology and mechanism-of-action studies in chronic lung diseases. The role emphasizes primary airway biology, epithelial-stromal...Senior
$170k - $200k
A biotechnology company in South San Francisco is seeking a Senior Clinical Scientist to join their Clinical Development team. This hybrid role involves supporting clinical trial designs and working with cross-functional teams to bring innovative therapeutics to market...Senior
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