Global Regulatory Strategy Lead
1 week ago
At Genmab, we are dedicated to building extraordinary futures by developing innovative antibody products that change lives. Our mission is to improve the lives of patients through groundbreaking medicines.
We strive to create a global workplace where individuals' unique contributions are valued and drive innovative solutions. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science.
The RoleWe are seeking an Associate Director, EU/ROW Regulatory Lead to be part of our Global Regulatory Affairs organization. In this role, you 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.
The candidate may also be allocated as EU/ROW Regulatory Strategy Lead to one or multiple compounds in early or late development, providing regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team.
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 develop and execute EU/ROW regulatory strategies.
- Lead 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 updated knowledge of regulatory topics and participate in maintaining and preparing regulatory processes and ways of working.
This position requires strong project management skills, attention to detail, and the ability to solve problems independently. The ideal candidate will have a minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
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