My Client is one of the top pharmaceutical companies and it has 146 branches and more than 47 thousand employees worldwide.
Role: CMC Regulatory Manager
Responsibilities:
- Regulatory Strategy and Registration Activities
- Create, manage and review CMC and Regulatory Compliance related documents (including the application form) intended for submission to Health Authorities.
- Act as the contact point of GRLs for CMC, and Regulatory Compliance related matters, member of Regulatory Affairs sub team (RRL CMC JP, RL CMC JP) and LRL for assigned products/projects, where applicable
Requirements:
- Bachelor's degree in Pharmacy, life sciences, chemistry, or significant practical experience related to CMC, e-Submissions, and/or Regulatory Compliance
- In-depth knowledge of international regulatory requirements, including understanding, interpretation, and application of the regulatory legislation in Japan
- More than 3 years experience in RA including new drug registration
- Fluent in Japanese and good English communication skills
Please apply with a CV for more details.
