Associate Director, Global Regulatory Affairs Project Lead
1 week ago
We are seeking an experienced Associate Director to lead our Global Regulatory Affairs Project Lead team. As a key member of our organization, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple, often highly complex, clinical trial submission activities.
Key Responsibilities:
- Represent RA in the 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 the assigned project(s) and be responsible for the development and execution of the EU/ROW strategy.
- 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 and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
- Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working.
Requirements:
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. Master's degree preferred.
- Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
- Experience in proactively planning and executing highly complex clinical submission strategies.
- A good understanding of drug development and EU regulatory procedures. Experience within oncology will be a plus.
- Prior experience leading health authority meetings with the EMA or other health authorities. Experience with PIPs will be a plus.
- Strong project management skills.
About You:
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do. You 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.
- You 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.
- 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.
Location: Copenhagen, Denmark
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