Responsible for oversight of all regulatory subjects for marketed products, obtaining and maintaining approval within relevant regulations-Set the regulatory strategy for food products by assessing opportunities in the medical and general food space.
-Preparing drug application materials for partial change application and new drug registrations.
-Coordinating preparation of JNDA dossier and CTN packages, reviewing them to ensure efficient data presentation and quality with proper tools and systems. Manage registration process after JNDA filing
-Coordinate the official meeting with regulatory agencies and the preparation of documents
-Prepare and advise with commercial teams for filing applications for food products with food for sick and other functional foods claims and registrations.
-Manage strategies for new nutrition product introductions medical device regulatory filings.
-Coordinate accurate and timely pharmacovigilance reporting with support from medical affairs department.
BS in pharmacy, biology, chemistry, pharmacology, or related subject is required. Advanced degree, MS or Ph.D. is preferred.
-experience in Japan pharmaceutical regulatory or food regulatory area.
-Working knowledge of Japan Food law
-Communication with non-Japanese through English conversation required.
-Worked with commercial teams or has similar experience beyond core regulatory experience, demonstrating comfort level interacting with commercial / manufacturing functions.
-Familiar with regulatory requirements on quality (GMP, GQP, CMC)
Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja