Regulatory Affairs Specialist

Location Tokyo
Discipline Life Science
Job type Permanent
Salary Negotiatable
Reference 37028


A global medical device manufacturers



1. General business 30%:

  • Registration/examination of various information and documents based on requests from other departments

  • Aggregate the opinions of the team and propose appropriate measures for improvement work, etc.

  • Make and implement improvement proposals for normal operations

  • Training for new hires

2. Regulatory affairs 70%:

  • Aggregate the team's opinions on the team members' applications and support the planning of application strategies, etc.

  • Propose and implement an appropriate strategy from application to insurance coverage for the product in charge of application

  • Consideration of regulatory strategy for change communication on existing products

  • Appropriate preparation, maintenance, management and improvement of package inserts

  • Responding to regulatory requirements related to clinical trials/trials

  • Preparation and submission of insurance coverage request form (including B and C categories)

  • Demonstrate leadership in responding to new pharmaceutical regulations and propose team responses

  • Process support from approval to launch

  • Explain strategy and progress to global RAs regarding the product for approval

  • Plan and implement pharmaceutical law training for global RAs



Necessary conditions:

  • Bachelor's degree in chemistry, pharmacy or engineering or good product knowledge/experience in pharmaceutical/orthopedic field

  • Must have experience in pharmaceutical affairs. Have at least 5 years of experience.

  • Consistently meet standards for regulatory/quality/clinical requirements

  • Experienced success as a project leader

  • Has a successful track record of quality/analysis or business process development

Desirable conditions:

  • Chemistry, pharmacy, life sciences, engineering or other graduate level aptitude experience

  • Previously worked as a manager, etc. to lead the RA/QA/CL organization of an industrial association

  • Has a track record of obtaining approval in the application category (including clinical trials, applications based on clinical trials or clinical evaluation reports)

  • Working experience in pharmaceutical affairs at a global medical-related company

  • Good understanding of the medical system and industry associations in Japan