Director of EU Regulatory Strategy

3 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role
"Genmab is an international biotechnology company driven by its core purpose: to improve the lives of patients through innovative and differentiated antibody therapeutics. Our passionate team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to result in a proprietary pipeline including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates. We have formed strategic partnerships with biotechnology and pharmaceutical companies to help develop and deliver novel antibody therapies to patients. As a key member of our team, you will contribute to shaping the future of cancer treatment and serious diseases.
"Your key responsibilities will include:
  • Developing and executing the EU/ROW regulatory strategy for assigned project(s)
  • Collaborating with the Global Regulatory Team to ensure regulatory oversight of clinical trial submission activities
  • Representing RA in the Clinical Trial Teams and ensuring timely completion of clinical trials
  • Providing regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements
  • Acting as the primary contact with the EMA and coordinating with cross-functional teams to ensure optimal regulatory strategy

"To succeed in this role, you will require:
  • Strong knowledge of EU regulatory frameworks and guidelines
  • Experience in proactively planning and executing complex clinical submission strategies
  • Excellent communication and interpersonal skills
  • Ability to work independently and collaboratively within a global team
  • Strategic thinking and problem-solving skills


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