Regulatory Affairs Manager EU/ROW

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics. Our team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to create a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.

About the Job

We are seeking a Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization. This individual will represent RA in Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.

Responsibilities

  • Represent RA in Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
  • Represent EU/ROW in the Global Regulatory Team(s).
  • Act as EU/ROW Regulatory Lead for assigned projects and be responsible for the development and execution of the EU/ROW regulatory strategy.
  • Lead the preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, etc.
  • Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
  • Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working.

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 up to and including submission of global marketing authorization applications.
  • Experience in proactively planning and executing highly complex clinical submission strategies.
  • Prior experience leading health authority meetings with the EMA or other health authorities.
  • A good understanding of drug development and EU regulatory procedures.
  • Experience within oncology and/or I&I will be a plus.
  • Experience with PIPs will be a plus.
  • Experience with development and regulatory requirements in ROW markets will be a plus.
  • Strong project management skills.

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