Regulatory Affairs Director for Innovative Cancer Treatments

10 hours ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

At Genmab A/S, we are committed to transforming the lives of patients through groundbreaking antibody therapeutics. Our team of passionate innovators has developed cutting-edge technology platforms and leveraged translational research and data sciences to create a proprietary pipeline of innovative medicines.

About the Role

We are seeking an experienced Associate Director to lead our EU/ROW Regulatory Affairs team in developing and executing strategic regulatory plans for our cancer treatments. As a key member of our Global Regulatory Affairs organization, you will represent our interests in Clinical Trial Teams and work closely with internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.

This role requires a seasoned professional with extensive experience in Regulatory Affairs, preferably in development phases up to and including submission of global marketing authorization applications. You will be responsible for representing EU/ROW in the Global Regulatory Team(s) and acting as EU/ROW Regulatory Lead for assigned projects. Your expertise will be crucial in evaluating regulatory risks, recommending mitigation strategies, and monitoring changes in regulatory guidelines and regulations.

Your Key Responsibilities
  • Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
  • Represent EU/ROW in the Global Regulatory Team(s).
  • Act as EU/ROW Regulatory Lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW regulatory strategy.
  • Lead the preparation of strategic regulatory documents, e.g. 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 the cross-functional teams and management.
  • Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.

We offer a dynamic work environment with opportunities for professional growth and collaboration with a talented team of experts. If you are passionate about improving patient outcomes and have a strong background in Regulatory Affairs, we encourage you to apply.

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