Director of EU Regulatory Compliance
6 days ago
About the Job
This is an exciting opportunity to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. As a key member of our team, you will play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of clinical trial submission activities.
Key Responsibilities:
- Develop and execute the EU/ROW regulatory strategy for assigned projects
- Represent RA on Clinical Trial Teams and ensure regulatory oversight of clinical trial submission activities
- Evaluate competitive landscape and various regulatory mechanisms to optimize product development
- Lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, PRIME, etc.
- Plan, prepare, and lead EU and national Scientific Advice procedures as relevant
- Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management
- Maintain up-to-date 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 7-8 years of experience in Regulatory Affairs, preferably in development phase
- Significant experience in proactively planning and executing highly complex clinical submission strategies
- Solid understanding of drug development and EU regulatory mechanisms to expedite development
- Prior experience leading health authority meetings with EMA or other health authorities, as well as experience with PIPs
- Strong project management skills
About Us
- We are a passionate team dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics
- We believe in the power of collaboration and teamwork to achieve our goals
- We are committed to fostering a culture of innovation, creativity, and continuous learning
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