Global Regulatory Affairs Expert Seeking Exciting Opportunity

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking an experienced Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab.

Job Description

In this role, you will be responsible for representing RA in Clinical Trial Teams and ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW. You will also work closely with CROs and internal stakeholders to ensure regulatory compliance and strategy alignment.

You will have the opportunity to lead the preparation of strategic regulatory documents, plan and prepare EMA or national Scientific Advice procedures, and evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.

Key Responsibilities
  • Represent RA in Clinical Trial Teams and ensure regulatory oversight and progress of multiple 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 developing and executing EU/ROW regulatory strategies.
  • Lead the preparation of strategic regulatory documents, including Briefing Packages, ODDs, PIPs, etc.
  • Plan, prepare, and lead EMA or national Scientific Advice procedures.
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
Requirements

To succeed in this role, you will need:

  • A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field. A Master's degree is preferred.
  • Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
  • Experience in proactively planning and executing complex clinical submission strategies.
  • A good understanding of drug development and EU regulatory procedures.
  • Prior experience leading health authority meetings with the EMA or other health authorities. Experience with PIPs is a plus.
  • Strong project management skills.
About Us

Genmab is an international biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. We leverage translational research and data sciences to develop next-generation antibody technology platforms, resulting in a proprietary pipeline of bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.

We are proud to have formed 20+ strategic partnerships with biotechnology and pharmaceutical companies to help develop and deliver novel antibody therapies to patients. Our vision by 2030 is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

About This Opportunity

This is an exciting opportunity to join a dynamic team at Genmab and contribute to the development of innovative antibody therapeutics. As an Associate Director, Global Regulatory Affairs Project Lead, you will have the chance to work on high-profile projects, collaborate with cross-functional teams, and drive regulatory strategies forward.

The estimated salary for this role is around $120,000 - $160,000 per year, depending on location and experience. Please note that this figure is an estimate based on industry standards and may vary.

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