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]
- Compliance Management
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.
- Product Registration & Filing
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.
- Government & Regulatory Relations
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.
- Quality Management
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).
- Safety Management
Report adverse events to authorities as required by law.
Investigate safety issues, propose risk control measures, and ensure corrective actions are implemented.
- Documentation & Training
Plan and deliver training programs on regulations, quality processes, and safety reporting.
Evaluate training effectiveness and drive continuous improvement.
- Cross-functional Collaboration
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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