Regulatory Lead EU ROW Strategy Specialist

1 week ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time
Job Overview
Genmab A/S is committed to improving the lives of patients through innovative antibody therapeutics. We are currently seeking a highly skilled Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs team.

About the Position
The Associate Director, EU/ROW Regulatory Lead will play a critical role in representing Regulatory Affairs in Clinical Trial Teams and ensuring oversight and progress of multiple clinical trial submission activities. They will also act as EU/ROW Regulatory Lead for assigned projects, leading the development and execution of EU/ROW regulatory strategies. In addition, they will represent EU/ROW in the Global Regulatory Team(s) and lead the preparation of strategic regulatory documents such as Briefing Packages, ODDs, and PIPs. The ideal candidate will have a strong understanding of drug development and EU regulatory procedures, with experience in proactively planning and executing complex clinical submission strategies.

Duties and Responsibilities
The key duties and responsibilities of this role include:
  • Representing Regulatory Affairs in Clinical Trial Teams and ensuring oversight and progress of multiple clinical trial submission activities.
  • Acting as EU/ROW Regulatory Lead for assigned projects and leading the development and execution of EU/ROW regulatory strategies.
  • Representing EU/ROW in the Global Regulatory Team(s).
  • Leading the preparation of strategic regulatory documents such as Briefing Packages, ODDs, and PIPs.

Qualifications
To be considered for this role, the candidate should possess a minimum of 8 years of experience in Regulatory Affairs, preferably in the development phase up to and including the submission of global marketing authorization applications. A Bachelor's degree or equivalent in a scientific discipline or health-related field is required, with a Master's degree preferred. The ideal candidate will have prior experience leading health authority meetings with the EMA or other health authorities and a good understanding of drug development and EU regulatory procedures.

  • EU/ROW Strategy Lead

    4 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Overview We are looking for a highly motivated and dedicated individual to join our Global Regulatory Affairs organization as an Associate Director, EU/ROW Regulatory Lead. In this role, you will be responsible for representing RA in Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submissions. You will also act...

  • EU/ROW Regulatory Affairs Specialist

    1 week ago

    Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Genmab is an international biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our team has invented next-generation antibody technology platforms and harnessed translational, quantitative, and data sciences.We are looking for an Associate Director, EU/ROW Regulatory...

  • EU/ROW Regulatory Specialist

    2 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    About the PositionWe are seeking a highly experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization. As a key member of the team, you will be responsible for developing and executing the EU/ROW regulatory strategy for one or multiple compounds in early or late-stage development.Key Responsibilities:Develop and execute...

  • Associate Director for EU/ROW Regulatory Strategy and Compliance

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is a leader in the biotechnology industry, dedicated to developing innovative antibody therapeutics. As an Associate Director, Global Regulatory Affairs Project Lead, you will play a critical role in ensuring the success of our clinical trials in the EU and ROW regions.About the RoleIn this position, you will be responsible for representing RA in the...

  • EU Regulatory Strategy and Compliance Specialist

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    As an Associate Director, Global Regulatory Affairs Project Lead at Genmab, you will play a key role in ensuring the successful execution of clinical trials in the EU and ROW regions. In this position, you will be responsible for representing RA in the Clinical Trial Teams and working closely with the CRO and internal stakeholders to ensure regulatory...

  • Regulatory Affairs Leader EU/ROW

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Role OverviewWe are seeking a highly experienced Regulatory Affairs Leader EU/ROW 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 ensure operational...

  • Senior Director Regulatory Strategy EU/ROW

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Bold Leadership: Drive Strategic Growth in Regulatory Affairs at GenmabWe're seeking a seasoned leader to spearhead our Global Regulatory Affairs organization. The ideal candidate will develop global strategies to propel Genmab's portfolio forward, ensuring seamless execution of global submission activities. A strong interface with the EMA and oversight of...

  • Global Regulatory Strategy Lead

    1 week ago

    Copenhagen, Copenhagen, Denmark Genmab AS Full time

    At Genmab, we are dedicated to building extraordinary futures by developing innovative antibody products that change lives. Our mission is to improve the lives of patients through groundbreaking medicines.We strive to create a global workplace where individuals' unique contributions are valued and drive innovative solutions. Our people are compassionate,...

  • Regulatory Project Lead Specialist

    4 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    Job SummaryWe are looking for an exceptional Regulatory Project Lead Specialist to lead EU/ROW regulatory projects. In this role, you will assume responsibility for EU/ROW regulatory strategy and collaborate closely with the Global Regulatory Team. Your strong project management skills and attention to detail will ensure successful project outcomes.Key...

  • Regulatory Strategy and Operations Specialist

    3 days ago

    Copenhagen, Copenhagen, Denmark beBee Careers Full time

    We are seeking a Regulatory Strategy and Operations Specialist to join our team in Copenhagen, Denmark. This role will be responsible for developing and executing the EU/ROW strategy for assigned projects.In this position, you will work closely with the Global Regulatory Team to ensure compliance with EU/ROW regulatory requirements. Your key responsibilities...