Regulatory CMC Director

Job Title: Associate Director/Director, Regulatory CMCAt Upstream Bio, we are seeking an experienced Associate Director/Director, Regulatory CMC to lead our regulatory Chemistry, Manufacturing, and Controls (CMC) strategy for our biopharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance with global...

Job Title: Associate Director/Director, Regulatory CMCUpstream Bio is a pioneering biotech company dedicated to developing innovative therapeutics for inflammation. With a strong financial backing and a team of experts, we are pushing the boundaries of monoclonal antibody development. Our focus is on two Phase 2 studies in asthma and chronic rhinosinusitis...

Job SummaryDyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are seeking an experienced Associate Director, Regulatory Affairs CMC to join our team.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all...

Job Title: Manager, Regulatory CMCDeciphera Pharmaceuticals is seeking a highly skilled Manager, Regulatory CMC to join our Post-Approval Group within the Regulatory Affairs Organization. This role will be responsible for leading and executing post-approval CMC regulatory activities in support of our globally approved marketing applications.Key...

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...

Job Title: Associate Director, Regulatory CMCThe 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 Responsibilities:Lead CMC regulatory execution for...

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...

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 DescriptionOverview:At Alkermes, we are committed to developing medicines that address unmet patient needs. As an Associate Director of CMC Regulatory Affairs, you will play a critical role in supporting post-approval CMC changes and global Supply Chain and GMP activities for our marketed products.Key Responsibilities:Develop and lead regulatory CMC...

Job SummaryMythic Therapeutics is seeking a highly skilled Director/Senior Director of Regulatory Chemistry Manufacturing and Controls (CMC) to join our growing Regulatory Affairs team. This role will report to the Vice President Regulatory Affairs and will closely collaborate with Technical Operations, Quality, Clinical Operations, and other functions to...

Job Title: Director, Regulatory Affairs Job Summary: We are seeking a highly experienced Director, Regulatory Affairs to lead our regulatory strategy and operations. As a key member of our team, you will be responsible for developing and implementing a consolidated regulatory strategy to secure and maintain market access for our products. Key...

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...

CMC Manager Job DescriptionWe are seeking a highly skilled CMC Manager to join our team at Upstream Bio. As a key member of our organization, you will play a critical role in ensuring the timely delivery of high-quality drug substances and products.Key Responsibilities:Oversee contract development and manufacturing organizations (CDMOs) to ensure compliance...

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...

Job Title: CMC Manager, Drug SubstanceUpstream Bio is a biopharmaceutical company developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing, having raised $400M from high-quality investors. Our focus is on developing a monoclonal antibody targeting validated biology, with two Phase 2 studies in asthma and...

Job SummaryWe are seeking a highly skilled CMC Manager to join our team at Upstream Bio. As a key member of our organization, you will be responsible for providing strategic oversight of external contract development and manufacturing organizations (CDMOs) to ensure timely delivery of drug substance and drug product.Key ResponsibilitiesOversee CDMO...

Job Title: Executive Director, Regulatory AffairsCompany: Trebla TalentLocation: Massachusetts - HybridJob Type: Full-timeAbout the Company:Trebla Talent is a leading recruitment agency specializing in placing top talent in the biotech and pharmaceutical industries.Job Description:We are seeking an experienced Executive Director to lead our Regulatory...

Executive Director Regulatory AffairsJob Summary:Weber & Company is seeking an experienced Executive Director Regulatory Affairs to lead our client's regulatory affairs team in Greater Boston. As a key member of the leadership team, you will be responsible for developing and implementing a regulatory strategy that accelerates product approvals and maintains...

Associate Director of Regulatory OperationsDragonfly Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Operations to join our team. This role will play a crucial part in managing all aspects of regulatory submissions and operations to ensure compliance with global health authorities.Key Responsibilities:Regulatory Operations...

Job Title: Director Quality OperationsMural Oncology is a clinical-stage oncology company focused on discovering and developing immunotherapies that may improve the lives of patients with cancer. Our team is dedicated to ensuring compliance and excellence across all research and development activities, encompassing Good Clinical Practice (GCP), Good...