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
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
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
【FOR FURTHER INFORMATION】
Contact NAME: Jordan Grant-Leanna
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