EU/ROW Regulatory Strategy Director

7 days ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

Genmab A/S is a biotechnology company that aims to transform the lives of people with cancer and other serious diseases through innovative and differentiated antibody therapeutics. Our team has developed a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.

About the Position

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.

Key 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.

Personal Qualifications

  • Strong organizational, communication, and time management skills needed to lead multiple ongoing projects simultaneously.
  • Must have attention to detail and be able to solve problems with minimal supervision.
  • Be able to work independently with an ability to drive projects to successful outcomes.
  • Robust cross-functional teamwork skills and enjoy working in a global environment.
  • Skills in building and maintaining internal and external collaborative relationships to achieve shared goals.
  • Highly motivated and dedicated individual who enjoys being challenged.
  • Able to prioritize your work in a fast-paced and changing environment.
  • Goal-oriented and committed to contributing to the overall success of Genmab.

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