Regulatory CMC Manager

Job SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of...

About the RoleAlkermes, Inc. is seeking a highly skilled Senior Manager to join our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. As a key member of our team, you will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and our European office.Key ResponsibilitiesRegulatory...

Job Title: Associate Director, Regulatory CMCThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) plays a pivotal role in executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne's clinical registration, commercial development, and...

About Dyne TxDyne Tx is a clinical-stage biotechnology company dedicated to developing innovative therapeutics for people living with genetically driven diseases.Job SummaryWe are seeking a highly experienced Regulatory Affairs Director to lead our CMC regulatory strategies for our programs in early and late-stage development. This role will support our...

Job SummaryThe Associate Director, Regulatory Affairs CMC is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...

Job SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...

Job SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of...

About the RoleWe are seeking a highly motivated and experienced Scientific Marketing Director to join our growth team at Pharmaron Beijing Co. Ltd. This role provides an exciting opportunity to work on initiatives from inception to completion that make a significant impact on our business.Key ResponsibilitiesDevelop and Execute Comprehensive Marketing...

About Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop innovative small molecule medicines for challenging targets. Our initial focus areas include immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and...

About Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and develop...

About the RoleWe are seeking a highly skilled Senior Manager to lead our Chemical Development and Optimization team at GlaxoSmithKline. As a key member of our organization, you will be responsible for the development, optimization, implementation, and management of robust, cost-effective, and safe processes for the manufacture of small molecules, including...

Job Summary:We are seeking a highly experienced Global Regulatory Affairs Director to lead the development and execution of regulatory strategies for our vaccines portfolio. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring compliance with regional regulatory requirements and delivering the best possible labeling for...

Job Title: Regulatory Strategist / Project Manager (Biologics)Job Type: Contract-to-HireWork Arrangement: Hybrid (2-3 Days Onsite)Company: Thor CompaniesJob Summary:Thor Companies is seeking a highly skilled Regulatory Strategist with BLA experience to join our team on a contract-to-hire basis. As a Regulatory Strategist/Project Manager, you will be...

Company Overview:Syndax Pharmaceuticals is committed to advancing the future of cancer treatment, ensuring that individuals diagnosed with cancer can lead longer and improved lives.Position Summary:The Clinical Supply Chain Manager will oversee the management of investigational drug supplies for various global oncology trials. This role encompasses all...

Job Summary:Syndax Pharmaceuticals is seeking a highly skilled Clinical Supply Chain Manager to oversee the management of investigational drug supplies for multiple worldwide oncology trials. The successful candidate will be responsible for managing all aspects of clinical supply management, including packaging, labeling, distribution, inventory monitoring,...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewThermo Fisher Scientific Inc. stands as the premier entity in advancing scientific endeavors, boasting annual revenues surpassing $35 billion. Our mission is to empower our clients in creating a healthier, cleaner, and safer world. Whether our clients are propelling life sciences...

Position Overview: In this pivotal role, reporting to the Senior Director of Regulatory Affairs, the Senior Manager of Regulatory Affairs and Compliance will oversee the provision of expert regulatory guidance pertaining to the dissemination of information regarding designated Alkermes products and relevant therapeutic areas. This position collaborates...

Company Overview:AbbVie is dedicated to discovering and delivering innovative therapies that address significant health challenges today and in the future.Our goal is to positively impact lives across several key therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as through our Allergan Aesthetics portfolio.For further...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewThermo Fisher Scientific Inc. stands as the premier entity in advancing scientific endeavors, boasting annual revenues surpassing $35 billion. Our mission is to empower our clients in creating a healthier, cleaner, and safer world. Whether our clients are propelling life sciences...

Job OverviewThis position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.Key ResponsibilitiesLead analytical technology transfers, collaborating with teams and mitigating risks.Validate analytical methods...