Director of Regulatory Strategy

2 days ago


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 closely with CROs and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW. The chosen candidate may also be allocated as EU/ROW regulatory strategy lead for one or multiple compounds in early development, providing regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements.

Key Responsibilities:

  • Represent RA in Clinical Trial Teams and ensure oversight and progress of multiple clinical trial submission activities.
  • Represent EU/ROW in Global Regulatory Teams.
  • Act as EU/ROW regulatory lead for assigned projects and develop and execute EU/ROW strategies.
  • Lead preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc.
  • Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
  • Maintain updated knowledge of regulatory topics and regulations 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.
  • Experience in proactively planning and executing complex clinical submission strategies.
  • A good understanding of drug development and EU regulatory procedures. Experience within oncology will be a plus.
  • Prior experience leading health authority meetings with EMA or other health authorities. Experience with PIPs will be a plus.
  • Strong project management skills.


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