Regulatory Affairs Project Lead

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're dedicated to developing innovative antibody therapies that transform the lives of patients. Our passionate team of experts is committed to building extraordinary futures together, by pioneering cutting-edge treatments for serious diseases.

The Role & Department
We're seeking a highly skilled Regulatory Affairs Project Lead to join our Global Regulatory Affairs organization. In this critical role, you will assume responsibility for the EU/ROW regulatory strategy, collaborating closely with the Global Regulatory Team on one or multiple compounds in early or late-stage development. As the representative of RA on the Clinical Trial Teams, you will ensure regulatory oversight of clinical trial submission activities. Additionally, you will serve as the primary contact with the EMA, offering regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to both the Global Regulatory Team and Compound Development Team.

Key Responsibilities Include

  • Develop and execute the EU/ROW strategy for assigned projects
  • Represent RA in the Clinical Trial Teams and ensure progress of multiple clinical trial submission activities
  • Evaluate competitive landscape and various regulatory mechanisms to optimize product development
  • Prepare strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, and PRIME
  • Plan and lead EU and national Scientific Advice procedures as relevant
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management
  • Stay up-to-date on regulatory guidelines and regulations, and assess their impact on product development

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
  • Solid understanding of drug development and EU regulatory mechanisms
  • 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 transforming the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do, and 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 - Carl Jacobsens Vej 30

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