Associate Director Global Regulatory Affairs (m/f/d)
Otsuka Pharmaceutical Companies EuropeFrankfurt, Hesse, Germany
Posted April 11, 2025
Full Time
About the Company
Otsuka Pharmaceutical Companies Europe is dedicated to improving patient health through innovative solutions in neuroscience, nephrology, haemato-oncology, specialty care, and digital innovation. The company focuses on unresolved health issues and operates with integrity and ethical standards, aiming to help people live healthier lives.
Job Description
The Associate Director Regulatory Affairs provides global regulatory expertise to pre-clinical, clinical, and commercial areas for investigational and marketed products.
Requirements
- Comprehensive knowledge of the drug development process, drug laws, global regulations, and guidelines
- Experience leading submission of CTA, IND, sNDA/NDA/MAA/Variations
- University degree in Medicine, Pharmacy, Life Sciences or Chemistry
