Regulatory Affairs and Policy Lead

5 days ago


Copenhagen, Copenhagen, Denmark Ascendis Pharma Full time

At Ascendis Pharma, we are committed to making a meaningful difference in patients' lives. We are seeking a highly experienced Regulatory Affairs and Policy Lead to join our team and drive the development of our governmental affairs strategy.

This role will involve working closely with internal stakeholders to ensure alignment with our core values and commercial ambitions. The successful candidate will have a proven track record of developing and implementing effective regulatory affairs strategies, as well as experience in pharmaceutical marketing or market access.

Key responsibilities include:

  • Developing and owning European & International markets disease policy positioning papers
  • Working with selected countries to articulate and plan policy initiatives
  • Leading cross-functional efforts into validating scientifically and clinically meaningful Ascendis positioning towards policy makers

We offer a challenging and rewarding work environment, where you will have the opportunity to contribute to the advancement of therapeutic innovations and improve patient lives worldwide.



  • Copenhagen, Copenhagen, Denmark Prolific Xpert Full time

    The Regulatory Affairs Consultant will play a crucial role in ensuring that our organization adheres to national and international legislation and guidelines regarding compliance and audits.Key DeliverablesDevelop policies and procedures for compliance and risk managementConduct regular training sessions for employees on compliance and risk...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    At Genmab, we're driven to push the boundaries of innovation in developing groundbreaking cancer treatments and therapies.Director/Associate Director, Global Regulatory Affairs - CMCWe're seeking a seasoned Regulatory Affairs Director Lead to join our team and play a pivotal role in shaping the future of biologics development. As a key member of our CMC...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking an experienced and skilled individual to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. You will act as the representative of RA on Clinical Trial Teams...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Genmab A/S is dedicated to creating life-changing antibody therapeutics for patients with cancer and other serious diseases. As a Regulatora Affairs Strategist in our Global Regulatory Affairs organization, you will play a key role in shaping the regulatory strategy for our products.Your primary responsibility will be to support the Global Regulatory Lead...


  • 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....


  • 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 ExistDirector of Regulatory AffairsAre 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, seeks a...


  • 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 Genmab Full time

    We are looking for a highly skilled Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for ensuring regulatory compliance and facilitating the successful execution of clinical trials in the EU and ROW regions.About the RoleIn this position, you will be...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About the RoleGenmab is seeking an experienced Senior Manager/Associate Director to lead our Global Regulatory Affairs organization as EU/ROW Regulatory Lead. In this role, you will represent RA in Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.Key...


  • Copenhagen, Copenhagen, Denmark MasterCard Full time

    Senior Counsel, Regulatory AffairsSenior Counsel, Regulatory AffairsApply locations Copenhagen, Denmark time type Full time posted on Posted 22 Days Ago job requisition id R-242297Our PurposeMastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where...


  • Copenhagen, Copenhagen, Denmark MasterCard Full time

    Senior Counsel, Regulatory Affairs Senior Counsel, Regulatory Affairs Apply locations Copenhagen, Denmark time type Full time posted on Posted 22 Days Ago job requisition id R-242297 Our Purpose Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionWe are seeking a highly skilled and experienced Strategic Director of Regulatory Affairs to join our team at Genmab. In this role, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.You will provide strategic input and...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Join Our TeamWe are seeking an experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. The successful candidate will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of clinical trial...


  • Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    At Radiometer Danmark / Danaher, we're pushing the boundaries of healthcare innovation. Our mission is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you'll play a vital role in driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, our mission is to develop innovative antibody therapies that change the lives of patients. We are committed to excellence in all aspects of our work, including regulatory affairs.The RoleWe are seeking an Associate Director, Global Regulatory Affairs Project Lead, to join our team. In this role, you will be responsible for ensuring regulatory...

  • Compliance Manager

    2 weeks ago


    Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full time

    As a Compliance Manager - Regulatory Affairs, you will be responsible for handling change controls and deviations in GxP validated IT Systems. You will also act as an expert, ensuring compliance with regulatory guidelines and providing guidance on national and EU legislation within the regulatory field.About UsSandoz, a leader in generic and biosimilar...


  • Copenhagen, Copenhagen, Denmark MasterCard Full time

    Our PurposeMastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart, and accessible. Our technology and innovation, partnerships,...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    About the Role:Radiobotics ApS is looking for a highly skilled Quality Assurance/Regulatory Affairs Specialist to join our team.As a key member of our Clinical and Regulatory team, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices. You will collaborate with cross-functional teams, develop and implement QMS...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly skilled Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab. This individual will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.The successful candidate will work closely with...


  • Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    Company OverviewRadiometer Danmark / Danaher is a leading company in the diagnostics industry, working towards improving global healthcare with reliable, fast, and easy patient diagnoses. We are proud to work alongside a community of six fellow Diagnostics Companies at Danaher.Job DescriptionThe Senior Manager, RA Processes, Systems and Tools for Radiometer...