BRS Consultant
Elaine Montes
Medical Device
NEW
Job number: JN -052025-188683
Posted: 2025-05-23
Regulatory Affairs Specialist
Tokyo or Osaka OK
8 - 10 million yen
Osaka
Pharmaceutical
Regulatory Affairs
Job details
- Company overview
-
Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development. - Responsibilities
-
Main responsibilities:
- Work related to the preparation, maintenance, and management of clinical trial applications and attached documents
- Various consultations with regulatory authorities (PMDA, MHLW, etc.)
- Work related to approval applications (support for client applications)
- Work related to the collection, maintenance, and management of pharmaceutical information
- Other (participation in various meetings, training, etc.)
- Requirements
-
Minimum requirements:
- Experience in preparing and submitting clinical trial applications (including clinical trial consultation with PMDA): ~3 years or more
- Consultation with regulatory authorities regarding the development of new drugs and regenerative medicine products, and regulatory affairs experience related to approval applications (CMC, non-clinical, clinical) (including preparation of CTD/eCTD and obtaining approval): ~3 years or more
- University graduate or above (in science preferred)
- English proficiency (most recent TOEIC score of 750 or above, or equivalent)
- Salary
- 8 - 10 million yen
- Location
- Osaka