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 Lead to join our Global Regulatory Affairs organization. This role involves representing RA in Clinical Trial Teams and ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW.

Key Responsibilities
  1. Represent RA in Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
  2. Represent EU/ROW in the Global Regulatory Team(s).
  3. Act as EU/ROW Regulatory Lead for assigned projects and develop and execute EU/ROW regulatory strategies.
  4. Lead preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, etc.
  5. Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
  6. Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
  7. Maintain updated knowledge of regulatory topics and participate in maintaining and preparing regulatory processes and ways of working.
Requirements
  • A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. Master's degree preferred.
  • Minimum of +8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
  • Experience in proactively planning and executing highly complex clinical submission strategies.
  • Prior experience leading health authority meetings with the EMA or other health authorities.
  • A good understanding of drug development and EU regulatory procedures.

This position offers a challenging opportunity to work with highly motivated team members across functions in an informal, multicultural environment.

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