CMC Expert (Pharmaceutical industry)
東京23区
正社員
600万円 - 1500万円
- 応募
- 求人を送信
- 求人を保存
Bullet points
Visa sponsorship available
International work environment
企業情報
Japanese market leader in the Pharmaceutical (Animal Health) industry expanding their business both locally and globally.
職務内容
- Ensure contractors have applicable quality systems and comply with GMP / regulatory requirements
- Support or conduct Regulatory compliance assessment
- Act as QA focal point for regulatory communications and change
- promote CMC issues and represent CMC interests of development, production and quality in authority meetings
理想の人材
- M.Sc., B. Pharm, M. Pharm, Engineering, Chemistry, Biology or equivalent degree
- 3-5 years of experience in CLinical Development, Regulatory Affairs, Quality Affairs
- Successful experience in negotiations with regulatory bodies and experience writing CMC documents that comply with regulatory requirements
- Fluent in English, Conversational level in Japanese
条件・待遇
International work environment
Visa sponsorship available