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。
■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. Quality Management
- Oversee quality control across production, warehousing, and distribution.
- Develop inspection plans, conduct sampling tests, and analyze results.
- Draft quality reports, identify root causes of issues, and monitor corrective actions.
- Assist in developing and updating quality management system documents (e.g., SOPs, GMP compliance).
5. 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.
6. 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.
7. 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。
- 英語読解・文書作成ができれば尚可
- 論理的思考力、責任感、問題解決力を有し、一定のプレッシャー下でも業務遂行可能
- 高いコミュニケーション能力と協調性を持ち、法令遵守と社内規則を徹底できる方
[Others]
- 給与
:経験・資格・学歴を考慮の上、応相談 - 福利厚生
:
社会保険完備(健康保険、厚生年金、雇用保険、労災保険)
年次有給休暇(初年度10日、以後年次増加)、夏季休暇、年末年始休暇
通勤手当(実費支給、上限3万円/月)、通信手当
定期健康診断、福利厚生制度(通勤バス、社員割引など)
- キャリア開発
:社内昇進制度、業界研修や資格試験受験支援あり
==================================================
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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