Regulatory Affairs Manager CMC

About the RoleWe are seeking a highly skilled and experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs CMC team at Genmab. As a key member of our team, you will be responsible for providing strategic regulatory input to support worldwide development and commercialization of our products.The successful candidate...

Genmab A/S is a dynamic and innovative biotechnology company committed to developing groundbreaking antibody therapies for patients with cancer and serious diseases. We are seeking a seasoned CMC Regulatory Affairs Director to join our team, bringing expertise in global regulatory affairs for biological products.Job Description:Develop and execute...

CMC Regulatory Expertise SoughtWe are looking for a highly skilled Global Regulatory Affairs Manager to lead all global regulatory CMC activities during development, registration of worldwide market expansions, and CMC lifecycle activities for small molecules and peptide products.Your Key Responsibilities:Oversee the preparation of regulatory submissions and...

Key Responsibilities:The ideal candidate will be responsible for regulatory submissions and approvals for worldwide market expansions and approvals. They will provide regulatory CMC strategy and expertise to cross-functional teams. Additionally, they will perform regulatory impact assessment of CMC changes for development projects and established...

We are seeking a highly skilled and experienced professional to join our team as a Director Regulatory CMC. As a member of our Regulatory Affairs department, you will play a key role in developing and executing global regulatory strategies for biological products, ensuring compliance with regulatory requirements.Key Responsibilities:Develop and implement...

OverviewWe are seeking a highly experienced Regulatory Affairs professional to join our team in Copenhagen, Denmark. As a Director/Associate Director of Global Regulatory Affairs - CMC, you will be responsible for leading the development and execution of global regulatory strategies for biological products.Key ResponsibilitiesDevelop and execute sound and...

We are looking for a highly skilled professional to lead our Regulatory Affairs CMC team. The ideal candidate will have a Master's degree in pharmacy, engineering, or equivalent, with a minimum of 8+ years of industry experience within Regulatory Affairs CMC.ResponsibilitiesEvaluate and communicate regulatory risks and challenges.Liaise and negotiate with...

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Role SummaryWe are seeking a highly experienced professional to join our Regulatory Affairs CMC team. The ideal candidate will have a strong understanding of compliance and biologics, as well as experience in moving therapeutic products through various stages of development.

At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly unique,...