Regulatory CMC Director

About the Role:We are seeking a highly experienced Regulatory CMC Director to join our team at Neurocrine Biosciences. As a key member of our regulatory affairs team, you will be responsible for contributing to the strategy and execution of regulatory CMC plans for assigned development and commercial projects. Your expertise will be essential in ensuring the...

Job SummaryThe Director/Senior Director, Regulatory Affairs will lead the development and execution of innovative CMC regulatory strategies to support the global development and commercialization of a drug/device combination product. This role requires dynamic leadership and direction to multi-disciplined project teams, working collaboratively with...

Job Title: Regulatory Affairs Specialist - CMCNeurocrine Biosciences is seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and execution of regulatory strategies for assigned commercial and development projects.Key...

Job Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...

Company Overview: Ignite Human Capital is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer.Position Overview: We are seeking an accomplished and dynamic Senior Director of Regulatory Affairs...

Job OverviewIgnite Human Capital is seeking a seasoned Senior Director of Regulatory Affairs to spearhead regulatory strategies and activities concerning the development and approval of cell therapy products.This pivotal role will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objectives.Key...

Job SummaryKumquat Biosciences is a biotechnology company dedicated to the discovery and development of innovative drugs to transform cancer treatments. We are seeking a highly motivated and experienced CMC drug substance professional to join our CMC team in San Diego.This candidate will report to the senior director and head of CMC and work closely with our...

About the RoleiBio Inc is seeking a highly skilled CMC and Nonclinical Development Lead to oversee all Chemistry, Manufacturing, and Controls (CMC) activities and nonclinical toxicology studies. This role will play a crucial part in our regulatory submissions and will be responsible for advancing our innovative drug development programs from discovery to IND...

Job SummaryWe are seeking a highly skilled Senior Manager, CMC Program Management to join our team. This role will be responsible for driving effective execution of CMC deliverables through program and project management support.Key ResponsibilitiesProvide program management leadership, support, and facilitation for dynamic, cross-functional CMC TeamsBuild...

About Indapta Therapeutics Inc.Indapta Therapeutics Inc. is a clinical-stage biotechnology company harnessing the natural power of the immune system to fight hematologic and solid cancers with its universal natural killer (NK) cell platform.The company's allogeneic platform is based on a subset of NK cells, so-called g-NK cells that are derived from healthy...

Job DetailsJob Title: Senior Manager, CMC Program ManagementLocation: Remote Position type: FLSA: Full timeExempt Department: Portfolio Strategy & Program ManagementAt BioSpace, Inc., we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. We are revolutionizing...

Job DetailsJob Title: Senior Manager, CMC Program ManagementLocation: Hybrid / RemotePosition type: FLSA: ExemptDepartment: Portfolio Strategy & Program ManagementJob SummaryWe are seeking a highly skilled Senior Manager, CMC Program Management to join our team. The successful candidate will be responsible for driving effective execution of CMC deliverables...

Regulatory Affairs DirectorWe are seeking a highly motivated individual to provide leadership and support to global regulatory activities to achieve our strategic vision in obtaining worldwide approvals to market our products.The individual will represent Regulatory Affairs and work closely with cross-functional teams and development partners while managing...

Cytokinetics: A Leader in Muscle Biology and Cardiac Muscle PerformanceCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company dedicated to discovering, developing, and commercializing innovative muscle activators and inhibitors as potential treatments for debilitating diseases affecting cardiac muscle performance. With a strong...

Job Title: CMC Regulatory Affairs Data Entry SpecialistFoster City, CAJob Summary:RICEFW Technologies is seeking a highly skilled CMC Regulatory Affairs Data Entry Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Gilead RIM System to support key CMC RA...

Centivax is seeking a highly skilled CMC Project Lead to lead the development and GMP of novel mRNA vaccines and therapeutics. The ideal candidate will have a strong background in mRNA bioprocessing, molecular biology, and biochemistry, as well as excellent project management skills.The CMC Project Lead will be responsible for managing multiple projects from...

Job OverviewCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.This role will play a crucial part in the successful approval and launch of our medical...

Product Quality Leadership Position at AnaptysBioAnaptysBio is an immunology-focused, clinical-stage biotechnology company with a 19-year track record of discovering life-changing therapeutic antibodies. We are seeking a highly skilled Director of Product Quality to join our team and contribute to our mission of creating a work environment where every role...

Job Title: CMC Project LeadAbout the Role:We are seeking a highly skilled CMC Project Lead to join our team at Centivax. As a key member of our mRNA vaccine development team, you will be responsible for leading the development and GMP of novel mRNA vaccines and therapeutics.Key Responsibilities:* Lead project management for mRNA CMC and supply chain...

Job DetailsAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to achieve Alumis' strategic vision in...