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部署・役職名 | Regulatory Affairs QA Manager - pharmaceuticals (Japan) |
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Job Offer Summary: Title: Job Offer Summary: Title: pharmaceuticals Specialist Department: Regulatory Affairs Working Style: Hybrid Area: Toronomon, Tokyo Company Type: Foreign Multinational Age Limit: No Age limit for applicants Summary: Regulatory Affairs Manager position as expert of registration for pharmaceuticalss with PMDA. Responsibilities Monitor and guide the organization to improve in compliance with the latest J-PMD Law and related ordinances / regulations required for pharmaceuticals MAH (Manufacturing Authorization Holder). Participate in and facilitate cross functional team for new product introduction to provide expertise in regulatory strategies. Compile and register technical files for pharmaceuticalss Research assesses and/or consults to identify on regulatory requirements to register new or changed products. Assess and/or consult to identify GMP requirements to register new or changed products. Develop strategies and plans to register and/or launch assigned product and execute by coordinating internal and external stakeholders to complete its registration. Administer communication with the regulators to support their review of our regulatory applications. Monitor the progress of the preparation and review status by the local team outsource and regulator to update the international team and management at regular basis. Lead and consult preparation execution of reimbursements application. Monitor and assess regulatory impacts of new and revised regulations guidance and standard. Review and approve new and revision of design manufacturing input from the manufacturers suppliers to ensure the compliance along with Japanese regulatory requirements. Draft revise review consult and/or approve labelling to ensure the compliance to corporates requirement Japanese regulations. Review and/or approve labelling to ensure they are documented and produced in compliance to domestic internal requirements on GMP Register and maintain GMP Accreditation of pharmaceuticals. Register and maintain MAH manufacturing Repairing Distribution and other licenses necessary for local distributor of the products. Support QA team by providing regulatory insights to support creation and update of use/user’s manual PMS reporting and field actions. Participate in maintenance and improvement of regulatory and development processes to support compliances. EXPERIENCE 7 years or more of experience in regulatory affairs for pharmaceuticalss. 3 yrs. or more of experiences as one or more of representative of pharmaceuticals MAH (Sokatsu Hinseki or Anseki Preferred. SKILLS Experience with communication with PMDA or notified body reviewers. Good communication skills in English (written and oral) Excellent Communication Skills- inter department communication necessary. Sufficient PC skills to administer regulatory datasets and their revisions Excellent team player Preferred. Knowledge and experiences on pharmaceuticalss Experience on pre submission consultation with PMDA Experience to have participated in registration project with international stakeholders. Facilitator Good analytical and problem-solving skill Self-motivator and self-learner Specialist Department: Regulatory Affairs Working Style: Hybrid Area: Toronomon, Tokyo Company Type: Foreign Multinational Age Limit: No Age limit for applicants Summary: Regulatory Affairs Manager position as expert of registration for pharmaceuticalss with PMDA. |
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【勤務地】 Job Location : Japan , Tokyo 【雇用形態】 Job Type: Permanent Full-time (remote) |
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【歓迎(WANT)】 【REQUIRED QUALIFICATIONS】・3 years or more of experience in regulatory affairs for pharmaceuticals ・Experience with communication with PMDA or notified body reviewers. ・Good communication skills in English (written and oral) ・Sufficient PC skills to administer regulatory datasets and their revisions ・Excellent team player Preferred ・Knowledge and experiences on Surgical Devices ・Experience on pre submission consultation with PMDA ・Experience to have participated in registration project with international stakeholders. ・Experience or knowledge on GMP requirements ・3 yrs. or more of experiences as one or more of representative of pharmaceuticals MAH (Sokatsu Hinseki or Anseki) ・Facilitator ・Good analytical and problem-solving skill ・Self-motivator and self-learner 【GENERAL REQUIREMENTS】 ・Minimum Experience Level: 3-year ・Career Level: Mid-Career ・Minimum English Level: Daily Conversation ・Minimum Japanese Level: Native ・Visa Status: Permission to work in Japan required |
アピールポイント | 管理職・マネージャー |
リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
受動喫煙対策 | 屋内禁煙 |
更新日 | 2024/05/01 |
求人番号 | 3491816 |
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転職・求人情報の詳細をご覧になる場合は会員登録(無料)が必要です