Associate Director Regulatory Strategy

3 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

Job Overview:

Genmab is seeking a highly motivated and experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization. As the Global Regulatory Compliance Officer, you will be responsible for ensuring that Genmab's products comply with regulatory requirements in the EU/ROW region.

Key Responsibilities:

  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
  • Ensure regulatory compliance with EU/ROW regulations and guidelines.
  • Develop and maintain relationships with regulatory authorities in the EU/ROW region.

Requirements:

  • A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field.
  • Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
  • Strong knowledge of EU/ROW regulatory requirements and guidelines.


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