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Regulatory Affairs

  • Type Permanent
  • Salary ¥8000000 - ¥9000000 per annum + competitive
  • Location Tokyo, Japan
  • Sectors Regulatory Affairs

医療機器から医薬品と、グローバルで活躍する外資系製薬メーカー

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)

To find out more about Real Staffing, please visit www.apac.realstaffing.com

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