Senior Director, Regulatory Affairs Strategy-EU/RoW

4 dagen geleden

Utrecht, Utrecht, Nederland Genmab Voltijd
Job Title: Senior Director, Regulatory Affairs Strategy-EU/RoW

Genmab is seeking a highly experienced Senior Director to lead our Regulatory Affairs Strategy team in the EU/ROW region. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing regulatory strategies for our programs across all stages of development.

Key Responsibilities:
  • Develop and implement EU/ROW regulatory strategies in line with global development and commercial goals.
  • Lead or be responsible for planning and implementing regional regulatory procedures, including clinical trial applications, marketing applications, label extensions, and CMC changes.
  • Represent Regulatory Affairs across Genmab committees as indicated.
  • Evaluate and communicate regulatory risks and challenges to senior management, and provide mitigation options.
  • Oversee CRO quality, accountabilities, and deliverables related to Regulatory activities.
  • Assess EU and MHRA regulatory guidelines and regulations, and their impact on product development.
  • Interact with health authorities and lead/participate in health authority meetings.
  • Present regulatory strategies/positions to senior management and health authorities, as appropriate.
  • Evaluate regulatory mechanisms to optimize product development, and ensure their implementation, if applicable.
  • Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs.
Requirements:
  • A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field. PhD or MD degree preferred.
  • Minimum of 10 years of experience in Regulatory Affairs, across all development phases.
  • Significant experience in proactively planning and implementing complex clinical submission strategies.
  • Experience in leading a team of regulatory strategist professionals.
  • Expertise in drug development and EU regulatory mechanisms to expedite development.
  • Experience within oncology preferred.
  • Prior experience leading health authority meetings with the EMA or other health authorities.
  • Experience with submitting and bringing to completion MAAs in Europe/ROW.
  • Experience with variation procedures.
  • Strong project management skills.
About You:
  • You are passionate about Genmab's purpose and genuinely care about our mission to transform 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.

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