Antibody Therapeutics Project Lead

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time
Unlocking Innovative Cancer Treatment Opportunities

Genmab is a pioneering biotechnology company committed to developing groundbreaking antibody therapies that transform the lives of patients with cancer and other serious diseases. Our team of experts is dedicated to harnessing the power of innovative technology platforms, translational research, and data sciences to create next-generation medicines.

We are seeking an exceptional Antibody Therapeutics Project Lead to join our Global Regulatory Affairs organization. In this critical role, you will assume responsibility for driving the EU/ROW regulatory strategy for assigned projects, collaborating closely with cross-functional teams to ensure optimal product development.

Key Responsibilities:

  • Develop and execute EU/ROW regulatory strategies for multiple compounds in early or late-stage development
  • Represent RA on Clinical Trial Teams, ensuring regulatory oversight of clinical trial submission activities
  • Evaluate competitive landscapes and regulatory mechanisms to optimize product development and expedite market access in EU/ROW
  • Prepare strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, and PRIME
  • Plan and lead EU and national Scientific Advice procedures
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management
  • Maintain expertise on regulatory topics, guidelines, and regulations impacting Genmab products

Requirements:

  • A minimum of 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
  • Prior experience leading health authority meetings with EMA or other health authorities, as well as experience with PIPs

The estimated salary for this position is around $120,000-$180,000 per year, depending on location and experience. As a valued member of our team, you can expect a comprehensive benefits package, including opportunities for professional growth and development.

This role is located in Copenhagen, Denmark, and offers a hybrid work arrangement. If you are passionate about transforming lives through innovative cancer treatment, we encourage you to apply. We strive to maintain a diverse, inclusive, and equitable workplace where everyone feels valued and empowered to contribute their best work.

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