Regulatory Affairs Project Lead

1 week ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking a highly skilled and experienced Regulatory Affairs Project Lead to join our Global Regulatory Affairs organization at Genmab. As a key member of our team, you will be responsible for developing and executing the EU/ROW regulatory strategy for our compounds in early or late-stage development.

Key Responsibilities:

  • Develop and execute the EU/ROW regulatory strategy for assigned projects
  • Represent RA in Clinical Trial Teams and ensure regulatory oversight of clinical trial submission activities
  • Evaluate competitive landscape and regulatory mechanisms to optimize product development and expedite the path to market in EU/ROW
  • Lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, and PRIME
  • Plan, prepare, and lead EU and national Scientific Advice procedures as relevant
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management
  • Monitor and assess regulatory guidelines and regulations and their impact on Genmab products

Requirements:

  • Bachelor's degree or equivalent in a scientific discipline or health-related field; Master's degree preferred
  • Minimum 7-8 years of experience in Regulatory Affairs, preferably in development phase
  • Significant experience in proactively planning and executing complex clinical submission strategies
  • Solid understanding of drug development and EU regulatory mechanisms to expedite development; experience in oncology a plus
  • Prior experience leading health authority meetings with the EMA or other health authorities, as well as experience with PIPs
  • Strong project management skills

About You:

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do; you are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so

Location: Copenhagen, Denmark - Carl Jacobsens Vej 30

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