RA Specialist or Sr. Specialist

Location: Tokyo, Japan Salary: ¥6000000 - ¥7500000 per annum + competitive
Sector: Regulatory Affairs (RA) Type: Permanent


Good work-life balance
Possible to work from home 1-2 days a week
Very friendly for working mothers
Great atmosphere at work

    • To prepare, submit and maintain regulatory filing with relevant healthcare authorities (PMDA, RCB etc.)
    • To handle NPI registration per SMJ's business plan.
    • To control RA database in SMJ.
    • To conduct administrative project related work if required.
    • Timely execution of Regulatory Activities to enable products to be approved or accepted when planned.
    • Ensure Japanese regulatory requirements for the following Regulatory Activities:renewals of existing products;registrations related to product changes and;
    • responses to regulatory agency questions arising after a submission
    • registrations and renewals of FMR;
    • registrations of products that are new to Japan;
    • Provide Regulatory Submission Strategy and Timelines
  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

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