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Director of Global Regulatory Affairs
2 months ago
Takeda Pharmaceutical is seeking a highly skilled and experienced Director of Global Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing regulatory strategies for assigned products, ensuring compliance with global regulations and guidelines.
The ideal candidate will have a strong understanding of scientific principles and regulatory requirements relevant to global drug development and post-market support. You will be able to analyze complex issues, communicate effectively with cross-functional teams, and provide strategic recommendations to drive regulatory success.
This is an exciting opportunity to join a world-class R&D organization and contribute to the development of innovative therapies that improve patient outcomes.
Key Responsibilities:- Develop and execute regulatory strategies for assigned products, ensuring compliance with global regulations and guidelines.
- Collaborate with cross-functional teams to ensure regulatory compliance and drive project execution.
- Analyze complex issues and provide strategic recommendations to drive regulatory success.
- Communicate effectively with stakeholders, including Health Authorities, Alliance Partners, and internal teams.
- Stay up-to-date with changing regulatory requirements and guidelines, and apply this knowledge to inform regulatory strategies.
- BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.
- 8 years of overall biopharmaceutical/device industry experience with 5 years pharmaceutical Regulatory CMC or Device experience.
- Strong understanding of scientific principles and regulatory requirements relevant to global drug development and post-market support.
- Proven ability to analyze complex issues and communicate effectively with cross-functional teams.
- Ability to stay up-to-date with changing regulatory requirements and guidelines.
Takeda Pharmaceutical is a global, innovation-driven company that brings better health and a brighter future to people around the world. We are committed to creating a diverse and inclusive workplace that values the contributions of all employees.
We offer a competitive compensation package, including a base salary range of $149,000 to $234,300, as well as opportunities for professional growth and development.
