Regulatory Affairs Manager||薬事マネージャー

Company overview: top 4 oporthopedic copmany focused in: sports medicine, extremities, trauma, spine, and related surgical products. The Company's products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues.

Job Summary:
This position is responsible for managing all facets of regulatory and market access support Trauma, Spine, Sports & Surgical businesses. In addition to managing projects and leading a team of market access professionals, this position involves interaction with government authorities and hands on work in dealing with product submissions. In order to achieve Company objectives, a comprehensive understanding of products and their use, as well as an understanding of regulations and their application is required.

Principal Duties and Responsibilities:

Overall management of Trauma, Spine, Sports & Surgical product segments projects, including working closely with regional RA & Global manufacturing sites to drive reduction of registration cycle time through Speed to Market initiatives.


Define and implement Japan regulatory & reimbursement strategies and plans
Manage and track Speed to Market performance for Japan
Update registration cycle time metrics on a quarterly basis
Update comprehensive commentary report on a yearly basis
Create application documents (new/supplement/ninsho) and follow process through to approval
Partner with Clinical Affairs department for regulatory clinical studies
Partner with QA/QC to create and review labeling
Partner with MA to create C1 Reimbursement application
Provide guidance and consultation for regulation
Oversee and ensure development, implementation and compliance of relevant SOPs and Regulatory Affairs standard processes
Oversee Trauma, Spine, Sports & Surgical segment products review advertising and promotional materials and relevant internet activities and publications to comply with all relevant internal policies and local country regulations
Plan and successfully manage Japan Trauma, Spine, Sport & Surgical segment RA Budget and resources
People management including recruiting, coaching, team building, encouraging employee engagement and employee appraisal

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e. KSAs)


Superior people management and leadership skills
Highly motivated and strong project management skills
Strong strategic mindset and hands on approach
Excellent communication and interpersonal skills
Responsible, professional, detail oriented and patient
Proficient in reading, writing and speaking English (TOEIC 750+)

Education/ Experience Requirements


Bachelor’s Degree in Life Sciences, technical (engineering) or related field; advanced degree in engineering advantageous
12 – 15 years experience in medical industry, with a minimum of 5 years experience in a Regulatory Affairs role
3 - 5 years people management experience
Experience in electrical equipment and combination products regulations is strongly preferred
A combination of education and experience may be considered


Travel Requirements
Occasional domestic and international business trips

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