Current jobs related to Global Biologics Regulatory Professional - Copenhagen, Copenhagen - Genmab AS

  • Regulatory Affairs Leader for Biological Products

    1 day ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    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...

  • Global Biologics Strategy Leader

    5 days ago

    Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Join us at Genmab A/S, where you will have the opportunity to make a significant contribution to the development of groundbreaking antibody therapies. As a Global Biologics Strategy Leader, you will be responsible for creating and executing global regulatory strategies for biological products, ensuring compliance with regulatory requirements.Key...

  • Biologics Regulatory Affairs Strategist

    5 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    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.

  • Global Regulatory Strategist

    5 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Transformative Role in Biologics and Combination ProductsThis pivotal position drives the development of global regulatory strategies for clinical trials, focusing on Phase 2 and beyond.You will oversee preparation, review, and submission of INDs, CTAs, and other crucial regulatory filings. Effective collaboration with cross-functional teams and regulatory...

  • Global Regulatory Leader

    1 week ago

    Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    We are seeking an experienced Director of Regulatory Affairs to join our team at Black Swans Exist. As a key member of our organization, you will play a crucial role in shaping the future of women's health.Job DescriptionIn this challenging and rewarding role, you will be responsible for driving the regulatory framework for clinical development, Phase 2, and...

  • Global Regulatory Strategy Lead

    1 week ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Key ResponsibilitiesDevelop and execute global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.Collaborate with cross-functional peers to facilitate and optimize product development.Plan, review, and prepare CMC documentation for clinical applications, marketing authorization applications, and health...

  • Global Regulatory Lead

    3 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    We are seeking a dedicated professional to provide strategic regulatory CMC input to support worldwide development and commercialization. The ideal candidate will have a strong understanding of EU, US, and selected worldwide regulatory legislation for CMC topics.RequirementsMaster of Science in pharmacy, engineering, or equivalent.Minimum of 8+ years of...

  • Director Regulatory CMC

    5 days ago

    Copenhagen, Copenhagen, Denmark Genmab AS Full time

    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...

  • Regulatory Affairs Expert

    3 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Seeking an experienced professional to drive regulatory strategies for CMC topics. The ideal candidate will have a strong understanding of compliance and biologics, with a proven track record in moving therapeutic products through various stages of development.Key ResponsibilitiesDevelop and execute global regulatory CMC strategies for biological products...

  • Regulatory Affairs Strategist

    1 week ago

    Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Black Swans Exist is revolutionizing women's health by developing innovative biologics, combination drug-device products, and companion diagnostics. We seek a visionary Director of Regulatory Affairs to lead our global regulatory strategies.About the RoleThis high-impact position drives the regulatory framework for clinical development, Phase 2, and beyond....

Global Biologics Regulatory Professional

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

We're committed to transforming lives through innovative antibody therapeutics at Genmab, and we need passionate individuals like you to help drive this mission forward.

Director/Associate Director, Global Regulatory Affairs - CMC

This is a unique opportunity for a skilled Global Biologics Regulatory Professional to join our Regulatory Affairs CMC team and make a meaningful impact in the field of biologics development. As a key contributor to our CMC Regulatory strategy, you will be responsible for planning, preparing, and submitting CMC documentation to support product approvals.

You will work closely with our CMC organization to evaluate and mitigate regulatory risks, develop and execute global regulatory strategies, and provide advice and guidance on regulatory CMC topics. Your excellent collaboration and communication skills will enable you to effectively work with cross-functional teams and negotiate with global health authorities.

  • Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.
  • Provide advice and guidance on EU, US, and selected worldwide regulatory legislation for CMC topics.

To succeed in this role, you'll need:

  • A Master's degree in pharmacy, engineering or equivalent.
  • Minimum 8+ years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics.
  • Experience working in a fast-growing, dynamic company (or a strong desire to).