Head of EU Regulatory Compliance

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

As Head of EU Regulatory Compliance, you will be responsible for ensuring that all regulatory requirements are met for our clinical trials in EU/ROW. This includes developing and implementing EU/ROW strategies, collaborating with CROs and internal stakeholders, and preparing and submitting regulatory documents.

You will represent RA in Clinical Trial Teams and work closely with EMA and national health authorities to ensure compliance with regulatory requirements. You will also have the opportunity to act as EU/ROW regulatory strategy lead for one or multiple compounds in early development, providing regulatory expertise and guidance on procedural matters and documentation requirements.

Responsibilities:

  • Develop and implement EU/ROW strategies for assigned projects.
  • Collaborate with CROs and internal stakeholders to ensure timely and successful completion of clinical trial submissions.
  • Prepare and submit regulatory documents, including Briefing Packages, ODDs, PIPs, etc.
  • Liaise with EMA and national health authorities to ensure compliance with regulatory requirements.

Requirements:

  • A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. Master's degree preferred.
  • Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
  • Proven track record of success in regulatory affairs, with a focus on clinical trial submissions.
  • Strong understanding of EU regulatory procedures and experience within oncology will be a plus.
  • Prior experience leading health authority meetings with EMA or other health authorities will be a plus.
  • Excellent communication and project management skills.

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