Global Regulatory Affairs Project Lead

6 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're dedicated to developing life-changing antibody therapies for patients with cancer and other serious diseases. Our innovative approach combines cutting-edge science and translational research to deliver novel treatments.

About the Role

This is an exceptional opportunity to join our Global Regulatory Affairs organization as a key strategic advisor. In this capacity, you will assume responsibility for the development and execution of EU/ROW regulatory strategies for assigned projects. Your primary focus will be on ensuring optimal regulatory oversight of clinical trial submissions and representation in Clinical Trial Teams.

Your Key Responsibilities:

  • Evaluate competitive landscapes and regulatory mechanisms to optimize product development and expedite market entry in EU/ROW.
  • Develop and execute comprehensive EU/ROW regulatory strategies for multiple complex projects.
  • Represent RA in Clinical Trial Teams and ensure progress of clinical trial submission activities.
  • Prioritize and manage competing tasks and responsibilities while maintaining attention to detail and problem-solving skills.
  • Maintain up-to-date knowledge of regulatory guidelines, regulations, and current landscapes affecting Genmab products.
  • Contribute to the overall success of Genmab by collaborating with cross-functional teams and providing expertise on EU/ROW procedural matters.

Requirements:

  • A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field; Master's degree preferred.
  • A minimum of 7-8 years of experience in Regulatory Affairs, preferably in development phase.
  • Strong project management and leadership skills, with experience in proactively planning and executing complex clinical submission strategies.
  • Experience working with EMA or other health authorities, as well as PIPs, is highly desirable.

About You:

  • You are passionate about transforming lives through innovative cancer treatment and care deeply about Genmab's mission.
  • You bring rigor and excellence to all aspects of your work, believing in a rooted-in-science approach to problem-solving.
  • You are a collaborative team player who can work effectively with diverse backgrounds and skill sets.
  • You thrive in fast-paced environments and are determined to excel in your role while contributing to the overall success of Genmab.

Location: Copenhagen, Denmark (hybrid position)

Salary Range: €80,000 - €120,000 per annum, depending on qualifications and experience.



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