外資・化粧品/美容メーカーが日本進出にあたり、以下ポジションの方を募集いたします。
この2年間の成長率は、2023年45%超、2024年35%超
■進出のステージから参画できる貴重なチャンスのポジションです。
新たな環境でチャレンジをされたい、キャリアを形成されたいという方はぜひご応募くださいませ。
本社側のRAチームがサポートに入ります。
■メインの業務は薬事ですが、品質管理も一部お願いする可能性がございます(ご経験により相談)
募集職種:Regulatory Affairs Specialist OR Manager
- 勤務地
:東京都(通勤可能圏内) - レポートライン:品質管理部 部長(海外)
[Job Responsibilities]
1. Compliance Management
- Support the establishment and operation of compliance systems for pharmaceuticals, quasi-drugs, and cosmetics.
- Ensure business processes comply with Japan's Pharmaceutical and Medical Device Act, Pharmacist Act, and Cosmetics Act.
- Monitor regulatory updates, assess risks, and propose countermeasures.
2. Product Registration & Filing
- Manage product registration and filing processes with MHLW and PMDA.
- Prepare, submit, and follow up on application documents for pharmaceuticals, quasi-drugs, and cosmetics.
- Oversee certificate renewals, modifications, and archiving of registration documents.
- Maintain a database of registration information and track approval status.
3. Government & Regulatory Relations
- Build strong communication with MHLW, PMDA, and local health authorities.
- Track regulatory trends, inspections, and industry supervision updates, and share insights internally.
- Support inspections and investigations, prepare materials, and ensure timely responses.
- Represent the company at industry associations and maintain a positive corporate image.
4. Safety Management
- Collect and analyze product safety data, including customer feedback and adverse event reports.
- Report adverse events to authorities as required by law.
- Investigate safety issues, propose risk control measures, and ensure corrective actions are implemented.
5. Documentation & Training
- Organize and manage compliance and quality documentation, ensuring accuracy and traceability.
- Plan and deliver training programs on regulations, quality processes, and safety reporting.
- Evaluate training effectiveness and drive continuous improvement.
6. Cross-functional Collaboration
- Partner with production, sales, R&D, and procurement teams to ensure compliance at each stage.
- Provide guidance during R&D, highlight quality risks during sales, and support smooth operations.
- Participate in project meetings to resolve compliance and quality issues across departments.
[Requirement]
- 化粧品関連会社もしくは医薬系での同経験(今回の商品は化粧品です)。
- 部門立ち上げの経験などをお持ちですとアドバンテージ。
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弊社について>
Kingfisher HR Solutions Group
■HQ:上海。世界15オフィスにて展開中。
■人材紹介、RPO、HRコンサル、タレントマッピング、リテイナーサーチ等。
みなさまの日本国内もしくは海外就職をアシストさせてください。
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