CMC Expert (Pharmaceutical industry)
Tokyo 23 Wards
Permanent
¥6,000,000 - ¥15,000,000
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Bullet points
Visa sponsorship available
International work environment
About Our Client
Japanese market leader in the Pharmaceutical (Animal Health) industry expanding their business both locally and globally.
Job Description
- 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
The Successful Applicant
- 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
What's on Offer
International work environment
Visa sponsorship available