Senior Regulatory Affairs Lead
2 months ago
Genmab is seeking a Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization.
Key Responsibilities- Represent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.
- Work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.
- 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, such as 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.
- Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
We're looking for a highly motivated and dedicated individual who is passionate about our purpose and genuinely cares about our mission to transform the lives of patients through innovative cancer treatment.
You bring rigor and excellence to all that you do and are a fierce believer in our rooted-in-science approach to problem-solving.
You are a generous collaborator who can work in teams with diverse backgrounds and are determined to do and be your best and take pride in enabling the best work of others on the team.
You are not afraid to grapple with the unknown and be innovative and 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.
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