Global Regulatory Strategy Expert

5 days ago

Copenhagen, Copenhagen, Denmark Genmab Full time

About This Opportunity

We're looking for an experienced Global Regulatory Strategy Expert to join our team at Genmab. As a key member of our Global Regulatory Affairs organization, you'll play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects. Your expertise will be essential in ensuring regulatory compliance and facilitating the development of novel antibody therapeutics.

The Role & Responsibilities

In this role, you'll collaborate closely with the Global Regulatory Team to develop and execute the EU/ROW regulatory strategy, ensuring regulatory oversight of clinical trial submission activities. You'll also serve as the primary contact with the EMA on EU/ROW procedural matters and documentation requirements, providing regulatory expertise and guidance to both the Global Regulatory Team and Compound Development Team.

Key responsibilities include:

  • Develop and execute the EU/ROW regulatory strategy for assigned project(s) and ensure regulatory compliance
  • Collaborate with the Global Regulatory Team to ensure timely completion of clinical trial submission activities
  • Evaluate competitive landscape and various regulatory mechanisms to optimize product development and present options and recommendations to expedite the path to market in EU/ROW
  • Lead the preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, PRIME etc.
  • Plan, prepare, and lead EU and national Scientific Advice procedures as relevant
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management
  • Maintain updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working

Requirements

  • Bachelor's degree or equivalent in scientific discipline or health-related field; Master's degree preferred
  • Minimum 7-8 years of experience in Regulatory Affairs, preferably in development phase
  • Significant experience in proactively planning and executing highly complex clinical submission strategies
  • Solid understanding of drug development and EU regulatory mechanisms to expedite development; experience within oncology a plus
  • Prior experience leading health authority meetings with the EMA or other health authorities, as well as experience with PIPs
  • Strong project management skills

Personal Requirements

  • Strong organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously
  • Attention to detail and problem-solving skills with minimal supervision
  • Able to work independently and drive projects to successful outcomes
  • Cross-functional teamwork skills and ability to work in a global environment
  • Building and maintaining internal and external collaborative relationships to achieve shared goals
  • Motivated and self-driven individual who enjoys being challenged
  • Able to prioritize work in a fast-paced and changing environment
  • Goal-oriented and committed to contributing to overall success of Genmab

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