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
- 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...SuggestedWork at office
$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- ACADIA Pharmaceuticals Inc. seeks a Director, Regulatory CMC to lead global regulatory CMC strategies for small molecule programs from development through commercialization. You will advance development, regulatory submissions, and lifecycle management across key regions...Suggested
- ...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
- Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory strategies for small molecule therapies from development through commercialization worldwide. In this leadership role, you will guide CMC submissions, regulatory interactions, and lifecycle...Worldwide
$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...$258k - $320k
...experienced team has secured partnerships with leading global biopharmaceutical companies, generating a... ...: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects across all phases of development, including...Work at officeWorldwideRelocation package$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$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$189.7k - $237.1k
...average Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development through... ...leadership position, you will develop and execute global regulatory CMC strategies that support clinical...Work at officeLocal areaRemote workWorldwideNight shift3 days per week- 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... .../IMPD and NDA/MAA submissions, preferably in small molecules. #J-18808-Ljbffr Kardigan
- 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
$248k - $310k
..., every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports... ...to ensure on-time delivery of global, high-quality submissions across all... ...health authority interactions Prior small molecule experience preferred Excellent knowledge...$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... ...plans under pressure in a small, fast-paced...Full timeWork at officeLocal area2 days per week- 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...
- ...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
- Amgen is seeking a Senior Director of Small Molecule Drug Discovery in Inflammation to lead early discovery inflammation programs from target ID... ...record in leading cross-functional discovery efforts across chemistry, biology, and translational #J-18808-Ljbffr Amgen SA
- ...longer, fuller happier lives. Senior Director, Small Molecule Drug Discovery in Inflammation Discovery... ...early discovery through clinical and regulatory support. The Senior Director will... ...screening, medicinal chemistry, structural biology, PKDM and translational safety. The...Flexible hours
$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$265k - $285k
...comResponsibilities include: Provides regulatory leadership in support of... ..., Medical Affairs, CMC, and Quality to develop, coordinate, and implement global regulatory strategies and submissions... ...supporting development of biologics and/or small molecules, preferably in rare disease...- Amgen Inc. (IR) is seeking a Director for PKDM to lead small molecule portfolio strategy and development. This role involves driving the advancement... ...small molecule programs, with responsibilities including regulatory submissions and collaborative project leadership. The...
- Initial Therapeutics, Inc. is looking for a Director for PKDM leadership in small molecule portfolio strategy. The ideal candidate will lead cross-functional... ...teams, driving innovations in drug development and regulatory submissions, while recruiting and mentoring talent in...
$261k - $322k
..., Inc. in South San Francisco is seeking an experienced Intellectual Property Attorney to manage the company's IP function for small molecule products. This role involves reporting to the VP of Intellectual Property and requires onsite work four days a week. The ideal...$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...Full time$245k - $285k
...responsible for leading and managing the regulatory affairs within CMC function. This includes developing... ...a complex cell therapy product on a global basis. The successful candidate will... ...regulations and guidelines related to biologics drug development. Experience in the...Contract work- ...Pharmacology leader to steer the function across small molecules and biologics. You will guide PK/PD modeling, exposure-response analyses, and regulatory interactions while coordinating with... ...in a matrix environment to support global development and registration #J-18808-...
- Amgen in the United States seeks a Senior Director, Small Molecule Drug Discovery in Inflammation Discovery to lead early inflammation research for small molecule programs from target identification through preclinical assessment to IND/FIH. The role provides strategic...
- Amgen seeks a Senior Director of Small Molecule Drug Discovery in Inflammation to lead early inflammatory research from target identification to IND/FIH. You will define portfolio strategies for small molecule modalities and guide multidisciplinary teams across sites,...
$180k - $210.5k
...to courageously make the most complex biologics ever attempted to protect humankind.*LEAD... ...develops and executes multi-product global regulatory CMC strategies for investigational... ...ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos, CA...
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