Global CMC Regulatory Director Biologics & Small Molecules
Meet Life Sciences
Meet Life Sciences is seeking a Senior Director of Regulatory CMC to lead global regulatory strategies for clinical development and commercial products. The role requires deep CMC expertise across small molecules and biologics, exceptional negotiation with authorities, and a track record of successful submissions. The candidate will manage CTD modules and data packages, serve as the primary CMC contact, and work with cross-functional teams. #J-18808-Ljbffr Meet Life Sciences
- 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...Suggested
$232.6k - $287.4k
.... Position Summary The Director, CMC Quality Control - Small Molecules is responsible for providing... ...asset. Experience with biologics QC is considered an... ...resolution. Cross-Functional & Regulatory Engagement Collaborate... ...Experience supporting global regulatory submissions...SuggestedOngoing contractContract workLocal areaFlexible hours2 days per week3 days per week$302.01k - $390.83k
...DescriptionJOB DESCRIPTIONLead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives.Lead global... ...and cultural evolution of the Small Molecules organization while promoting...SuggestedFull timeFor contractorsLocal area- ...is seeking an experienced and highly motivated Small Molecule CMC Principal / Director to join a growing regulatory and product development consulting team. This role... ...-stage and commercial products across global markets.The successful candidate will provide scientific...SuggestedFlexible hours
- ..., a clinical-stage biopharmaceutical company, is seeking a Director of Regulatory Affairs CMC reporting to the VP of Regulatory Affairs to lead global CMC regulatory strategies for clinical-stage small molecule programs. This role partners with CMC, Technical Operations...Suggested
- 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...
- Ultragenyx Pharmaceutical Inc. is seeking a Director, CMC Quality Control - Small Molecules. This role provides technical and strategic oversight of outsourced QC activities for small molecule drug substances and products across development and commercialization, reporting...
$275k - $280k
...increase our understanding of the biology that controls human aging.... ...breakthroughs.Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to...- Ultragenyx is hiring for a Director, CMC Quality Control - Small Molecules to provide technical and strategic QC oversight for outsourced testing across... ...management, and cross-functional collaboration for regulatory submissions, inspections, #J-18808-Ljbffr Ultragenyx
- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs. Based in South San Francisco, you will partner with Regulatory Affairs, Quality, and Clinical teams...
- ...San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for our US and global programs. The role reports to the... .../IND and BLA/MAA filings for biologics, manage the CMC document control...
$275k - $280k
...happier lives! About the Job: The Senior Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies to accelerate... ...scientific fluency spanning across both small molecules and biologics, meticulous attention to detail, and the...Local areaRelocationRelocation package3 days per week$200k - $240k
Director, Small Molecule Discovery Biology (Inflammation & Autoimmunity) Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with...Work experience placement- Alumis Inc. is seeking a Director in autoimmune discovery biology to lead biology efforts for small molecule programs targeting autoimmune diseases. The role involves conceptualizing strategies, supervising chemistry and biology teams, and coordinating CRO studies to advance...
- Ultragenyx Pharmaceutical seeks a Director-level QC leader to oversee outsourced QC for small molecule drug substances and products across development and commercialization... ...JP standards. Responsibilities include leading regulatory submissions, inspections support, and...
$280k - $310k
...seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong... ...post-marketing CMC commitments, and global development programs across Mirum... ..., and regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs....Local area- Revolution Medicines in San Francisco is looking for an Associate Director, CMC Regulatory to lead the execution of regulatory strategies for clinical... ...collaboration with various teams to ensure compliance with global regulatory requirements. The ideal candidate will bring...
- 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 CMC plans, coordinate type... ..., with extensive experience in biologics and gene/cell therapy. Some travel (approx...
$220k - $270k
...Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical... ...strategies in compliance with global regulatory requirements for the development... ...communications skills with a strong background in small molecules, ideally solid-oral dose formulations...H1bCurrently hiring- Responsibilities Provide strategic PKDM-BA leadership for small molecule discovery and development programs, enabling... ...solving. Lead PKDM-BA contributions to regulatory submissions, including INDs, NDAs, and interactions with global health authorities. Define and execute...
$294.1k - $363.3k
...it most The Executive Director, CMC QA will provide strategic,... ...Ultragenyx programs inclusive of biologics, small molecule, gene therapy, and ASO.... ..., Supply Chain, Regulatory, and Quality stakeholders,... ...ICH, and other applicable global regulatory requirements, Ultragenyx...Full timeContract workWork at officeLocal areaFlexible hours2 days per week3 days per week- 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...Full time
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory strategies for drug approvals and submissions... ...or pharmaceutical industry and be adept at managing complex global submissions. The position is hybrid, with remote work and...Remote job$260k - $295k
...seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for... ...in the US and globally. The incumbent will be... ...Regulatory Affairs for biologics Bachelor’s Degree in biochemistry... ...under pressure in a small, fast-paced...Full timeWork at officeLocal area2 days per week$230k - $270k
...Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of... ...for developing and executing global Chemistry, Manufacturi ng, and... ...strategies for clinical-stage small molecule programs. This individual will...$195.5k - $272.5k
...motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all... ...conventional paradigms and influence global Health Authorities. We are looking... ...late stage and/or commercial large molecules (biologics) is required experience with combination...Full timeWork at officeWork visa3 days per week$244k - $305k
...in the RAS signaling pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy... ..., Medical Writing, Clinical Development, Biometrics, and CMC to deliver high-quality global submissions. Cross-Functional...Full timeLocal area- ...patients while transforming your career. Director - PKDM - Small Molecule Portfolio Strategy & Leadership What... ...through clinical development and regulatory submission. You will combine deep... ...including INDs, NDAs, and interactions with global health authorities. Define and...Flexible hours
$220k - $270k
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and excellent technical writing skills...$209k - $260k
...available, superior small molecule medicines that overcome... ...limitations of biologic and peptide drugs. We... ...financed by top-tier global life sciences investors... ...Operations, the Director Technical (CMC) Project Management... ...analytical, quality, regulatory, and supply chain activities...Contract work
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