Associate Director, Global Regulatory Affairs, Strategy; Europe & RoW

The Role

Associate Director, Europe/ROW Regulatory Lead to be part of our Global Regulatory Affairs organization. Represent European RA in the Global RA team and act as the Europe/ROW Regulatory Strategy Lead for one or more compounds in Phase I‑III development. Provide regulatory expertise and guidance on European/ROW procedural matters and documentation requirements to ensure an optimal regulatory strategy. Assigned to Clinical Trial Teams, work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in Europe/ROW.

Position is based in Copenhagen or Utrecht.

• Act as European/ROW Regulatory Lead for the assigned project(s) and be responsible for the development and execution of the European/ROW regulatory strategy.
• Represent Europe/ROW in the Global Regulatory Team(s).
• 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 the cross‑functional teams and management.
• Monitor and assess regulatory guidelines, regulations and the current regulatory environment/landscape and their impact on the development of Genmab products.
• Maintain updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working.
• Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.

• Bachelor’s degree or equivalent in a scientific discipline or health‑related field;
  Master’s degree preferred.
• Minimum of 8 years of experience in Regulatory Affairs, preferably 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 European regulatory procedures.
• Experience with in 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.

• Strong organizational, communication, and time‑management skills needed to lead multiple ongoing projects simultaneously.
• Attention to detail and the ability to solve problems with minimal supervision.
• Ability to work independently and drive projects to successful outcomes.
• Robust cross‑functional teamwork skills and enjoyment of 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.
• Ability to prioritize work in a fast‑paced and changing environment.
• Goal‑oriented and committed to contributing to the overall success of Genmab.

• You are genuinely passionate about our purpose.
• You bring precision and excellence to all that you do.
• You believe in our rooted‑in‑science approach to problem‑solving.
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds.
• You take pride in enabling the best work of others on the team.
• You can 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.