Regulatory Affairs Director

19 hours ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

At Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.

This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and collaboration skills. You'll work closely with our cross-functional teams to ensure seamless development and commercialization of our innovative products.

Your Key Responsibilities:

  • Develop and execute comprehensive global regulatory CMC strategies for biological products.
  • Collaborate with peers to facilitate and optimize product development.
  • Plan, review, and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
  • Provide expert advice on EU, US, and worldwide regulatory legislation for CMC topics.
  • Evaluate and communicate regulatory risks and challenges.

About You:

  • You have 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.
  • A track record in moving therapeutic products through various stages of development.
  • Experience with preparation of BLAs and preferably lifecycle management.
  • Excellent communication skills in English (verbal and written).


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Get AI-powered advice on this job and more exclusive features. Senior Business Development Consultant at Black Swans Exist Director of Regulatory Affairs Are you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health,...


  • Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    Radiometer Danmark/Danaher is proud to work at the forefront of diagnostic innovation. Our shared purpose unites over 4000 employees worldwide in a pursuit to improve patient care through technology and solutions.We are seeking an exceptional individual to join our Global Regulatory Affairs team as Senior Manager, RA Processes, Systems and Tools.As part of...


  • Copenhagen, Copenhagen, Denmark Pandora AS Full time

    About the JobPandora A/S is seeking a highly motivated and experienced Regulatory Affairs Director to lead our global regulatory affairs function. As a key member of our team, you will be responsible for ensuring that we maintain the highest standards of regulatory compliance and integrity.Main ResponsibilitiesDevelop and implement effective regulatory...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We are seeking a skilled and experienced Regulatory Affairs Director to join our team at Genmab A/S. As a key member of our Regulatory Affairs CMC team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About the Role:The Associate Director Regulatory Strategy will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. This role will represent EU/ROW in the Global Regulatory Team(s) and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Develop...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    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,...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Black Swans Exist, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a seasoned Director of Regulatory Affairs to spearhead their global regulatory strategies.About the RoleIn this high-impact position, you will drive the development and approval of innovative biologics, combination drug-device...


  • Copenhagen, Copenhagen, Denmark Tbwa ChiatDay Inc Full time

    Job Overview:The Senior Director of Global Regulatory Affairs will lead Tbwa Chiat/Day Inc's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business objectives. This role involves overseeing the company's engagement with regulatory bodies, shaping public policy initiatives, and ensuring seamless...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    We are looking for an exceptional individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring regulatory compliance and oversight for our clinical trials.In this role, you will represent RA in Clinical Trial Teams and...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the TeamOur Global Regulatory Affairs team is responsible for ensuring that Genmab's programs meet regulatory requirements and are developed and implemented in accordance with EU and international regulations. We work closely with cross-functional teams to ensure that our programs are developed and implemented in a way that meets regulatory...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the JobWe are seeking a seasoned Regulatory Affairs professional to join our Global Regulatory Affairs team. As a Senior Director, you will be responsible for the development and implementation of EU/ROW regulatory strategies for Genmab's programs across all stages of development. You will work closely with cross-functional teams to ensure an optimal...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Regulatory Affairs Expertise for a Leading Biotech CompanyWe are seeking a highly experienced and skilled Director of Regulatory Strategy and Operations to join our team at Genmab A/S. As a key member of the Global Regulatory Affairs organization, you will play a critical role in shaping the company's regulatory strategies and ensuring the successful...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to transforming the lives of patients through innovative cancer treatments. Our Global Regulatory Affairs organization is seeking a highly motivated and experienced individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead.This role will involve representing RA in Clinical Trial Teams and working...

  • Regulatory Director

    14 hours ago


    Copenhagen, Copenhagen, Denmark Tbwa ChiatDay Inc Full time

    The Regulatory Director will serve as a key regional leader for the company's regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing the unique requirements of local markets. Acting as a bridge between the VP of Public Policy & Regulatory Affairs, other Regional Regulatory Directors, and local teams, this...


  • Copenhagen, Copenhagen, Denmark Healthcare Businesswomen's Association Full time

    Job Description Summary LOCATION: Copenhagen, DenmarkROLE TYPE: Hybrid working (3 days per week in the office) As a member of the Regulatory Affairs (RA) team in Copenhagen, you will get the opportunity to work in a dynamic, agile team who has a common goal to bring our medicines to patients. We are looking for a Regulatory Affairs Manager or...


  • Copenhagen, Copenhagen, Denmark Tbwa ChiatDay Inc Full time

    General Role Overview: The Global VP/Head of Public Policy and Regulatory Affairs will lead AstroPay's global regulatory strategy, ensuring compliance, alignment and influence in a rapidly evolving fintech environment with a strong international focus. This executive role will oversee the company's engagement with regulatory bodies, shape public policy...


  • Copenhagen, Copenhagen, Denmark Macure Pharma Full time

    We are seeking a highly experienced Regulatory Publisher & Submission Manager to join our Regulatory Affairs Team in Copenhagen or Malta.As a key member of our team, you will be responsible for:Regulatory publishing: compiling, formatting, and validating regulatory submissions in eCTD.System implementation: playing a key role in the implementation of our new...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About GenmabGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. We leverage translational research and data sciences to develop next-generation antibody technology platforms, including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced...