EU/ROW Compliance Specialist
4 days ago
We are looking for a highly skilled and experienced Regulatory Affairs professional to join our team as an Associate Director, EU/ROW Regulatory Lead. In this role, you will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects, leading the preparation of strategic regulatory documents, and evaluating regulatory risks and recommending mitigation strategies to cross-functional teams and management.
Main Duties and Responsibilities- Develop and execute the EU/ROW regulatory strategy for assigned projects.
- Lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc.
- Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
- Represent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of multiple clinical trial submission activities.
- A minimum of 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 in development phase 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.
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com . Associate Director, EU/ROW Regulatory Lead page is loaded Associate Director, EU/ROW Regulatory Lead Apply locations Copenhagen time type Full time ...
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