Bio-pharmaceutical Company - Regulatory CMC Expert

Location: Tokyo, Japan
Job Type: 正社員
Salary ¥6000000.00 - ¥11000000.00 per annum
Specialization: ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産)
Sub-specialization 薬事
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お問合せ Eureka Teramura
参照 JO-1909-426774
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[Company Description]
Global Bio-pharmaceutical Company

[Responsibilities]
Regulatory CMC Expert
1. Serve as regional regulatory strategist for allocated product pipelines.

  • Develop regulatory CMC strategies considering regional requirements, category of applicable submission, scheduling and priority setting.
  • Ensure all local regulatory activities are in alignment with the strategic direction of the GRAST.
  • Contribute to a GRAST strategy setting providing regional CMC strategy.
  • Participate in GRAST meetings in charge.

2. Contribute to the compilation of relevant high quality documents for submissions for development products and/or established products in Japan, including new applications and partial change application, minor change notification, etc., and responses to questions, according to agreed schedules while taking into account regional regulatory requirements.

  • Ensure that dossiers meet the content and format requirements for the Japanese HAs.
  • Based on submission overviews, responsible for preparation and compilation of regional parts of CMC submission dossiers, e.g. CTD CMC parts, including application form.

3. Business / Marketing License maintenance

  • Plan necessary actions and timeline for regular license updates.
  • Communicate well with appropriate regional regulatory offices and prepare required documents for the licenses updates.
  • Maintain SOP for the licenses and ensure the Company (incl. branch) follows it.
  • In accordance with Global strategy, support to execute the negotiation, meetings and consultation, such as informal and formal consultation etc., for CMC issues / matters with Japanese Health Authorities.
  • Responsible for performing new applications, and partial change application and minor change notifications required to fulfill regional regulatory requirement.
  • Submit the relevant regulatory documents to the Japanese HAs in a timely manner.
  • Communicate submission dates and approval dates to stakeholders, as applicable.
  • Responsible for the overall coordination and dispatch/submission of responses to HAs questions directly to HAs.
  • Support the GRLs for the CMC strategy, planning and preparation of response for complex scientific questions requiring product expertise and contacting internal stakeholders.
  • Coordinate and participate at meetings with HAs.
  • Act as a Subject Matter Expert on regional, regulatory procedures and HA requirements
  • Develop and maintain effective working relationships with the Japanese HAs demonstrated by high quality communication and effective use of negotiation skills to achieve positive outcomes for the Company.

[Employment Type]
Full time

[Salary]
6-11M
(Experiences and skills will be considered)

[Location]
Tokyo

[Work Hours]
8:45am - 17:30

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Further details about the company and position will be notified at a later date.