Japan Regulatory Specialistの求人情報なら転職エージェントJAC


Japan Regulatory Specialist

  • 転勤なし
  • 週休二日制
  • 上場
  • 外資



会社名 外資製薬メーカー <業種:メディカル・バイオ - 製薬>


雇用形態 正社員(期間の定めなし)
勤務地 東京都

Regulatory Specialist will be the contact point for local, international and global cross functional teams on assigned project matters

a. Act as the key contact for Local Operating Company (LOC) stakeholders on regulatory topics pertaining to assigned projects

b. Prepare and maintain project plans and timelines of approvals and planned submissions

c. Support and align with other department and functions on needs re periodical requests form regulatory authorities

Fulfil regulatory filing requirements for Japan market approvals and lifecycle management for LOC commercialization on assigned projects

a. Evaluate local regulatory registration requirements for investigational and marketed products, prepare regulatory assessment reports

b. In conjunction with regulatory GRA BU Leads/GRL and International RA strategists, develop submission strategies; prepare project plans, timelines and related project fees

c. Review and submit investigational drug applications, market applications, post approval changes(include labelling), post approval reporting obligations and general product life cycle management with support of international strategists in charge of coordination of the application with non-clinical and clinical development teams, CMC, labelling and CROs when necessary.

d. Provide regulatory input to global and international strategist regulatory team and interact with regulatory agencies to resolve related review questions

e. Ensure the appropriateness of Japanese translation of English documents.

Regulatory contact point for Japanese regulatory authorities and external regulatory experts

a. Develop professional and effective working relationships with Japanese Regulatory Authorities and external regulatory experts

Liaise with marketing and commercial to ensure that all local product information used are up to date

Ensure compliance of regulatory activities in country that is consistent with Japanese law and Shire internal protocols and procedures

Members of local review teams according local regulations / requirements/codes and Policy for the review of

a. Local promotional and non-promotional materials

b. Local sponsorships to ensure compliance in close collaboration with QA and compliance team

Maintain regulatory documents, record keeping in secure, comprehensive manner

c. Develop meeting materials and attend meetings with regulatory agencies

d. Maintain a centralized archiv




・Minimum 8-10 years of experience with multinational pharmaceutical companies in regulatory affairs, prefer specialty drug experience

・Proven experience and relationship with Japanese Regulatory Authorities


年収 900万円 - 1500万円