Director, Global Regulatory Affairs, Strategy

Over de vacature

Overview

As Director, EU/ROW Regulatory Lead you drive regulatory strategy and oversight for EU/ROW trials within Genmab's Global Regulatory Affairs. You collaborate with CROs and internal teams to steer clinical submission activities and ensure timely approvals. You may lead EU/ROW strategy for one or more compounds and guide regulatory documentation and EMA interactions. This role supports Genmab's mission to transform cancer care through innovative antibody medicines and global regulatory excellence.

Arbeidsvoorwaarden / Benefits

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs
• Discretionary bonuses and long-term incentives

Verantwoordelijkheden

• Represent Regulatory Affairs in Clinical Trial Teams and oversee EU/ROW submission progress
• Represent EU/ROW in Global Regulatory Teams
• Lead EU/ROW regulatory strategy for assigned projects
• Lead preparation of strategic regulatory documents (Briefing Packages, ODDs, PIPs)
• Plan and lead EMA or national Scientific Advice procedures
• Evaluate regulatory risks and propose mitigation with cross-functional teams
• Monitor regulatory guidelines and their impact on development of Genmab products
• Maintain up-to-date regulatory knowledge and contribute to processes and ways of working

Belangrijkste vereisten

• Bachelor's degree (or equivalent) in scientific discipline or health-related field

• 8+ years in Regulatory Affairs, preferably in development up to global marketing authorization submissions

• Experience planning and executing complex clinical submission strategies

• Prior experience leading health authority meetings with EMA or other authorities

• Strong understanding of drug development and EU regulatory procedures

• Strong organizational, communication, and time management skills

• Attention to detail and problem-solving with minimal supervision

• Ability to work independently and drive projects to successful outcomes

• EU/ROW regulatory strategy

• Regulatory submissions planning and execution

• EMA and Scientific Advice procedures

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