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Senior Director Regulatory Strategy Development Lead

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time
Key Responsibilities
  • Develop global regulatory strategies through integration of regional regulatory strategies and alignment with global development and commercial goals
  • Lead or be responsible for planning and implementation of regional regulatory procedures (e.g., clinical trial applications, marketing applications, label extensions)
  • Represent Regulatory Affairs across Genmab committees as indicated
  • Evaluate and communicate regulatory risks and challenges to senior management, along with mitigation options
  • Oversee CRO quality, accountabilities, and deliverables related to Regulatory activities

This role requires strong project management skills, attention to detail, and problem-solving abilities. The successful candidate will work independently to drive projects to successful outcomes, prioritize tasks in a fast-paced environment, and collaborate with cross-functional teams.