Regulatory Affairs Manager / 薬事部長 兼 総括製造販売責任者
Job Information
- Job ID
- 90009
- Job Title
- Regulatory Affairs Manager / 薬事部長 兼 総括製造販売責任者
- Recruiter
- Way Simmons Partnership
- Division
- 薬事部
- Company Type
- International Company
- Job Type
- Full-time
- Location
- Tokyo - 23 Wards
- Salary
- 15 million yen ~ 18 million yen
- Work Hours
- ９：００～１８：００
- Holidays
- 週休二日制
- Date Refreshed
- Today
General Requirements
- Minimum Experience Level
- Over 3 years
- Career Level
- Mid Career
- Minimum English Level
- Business Level
- Minimum Japanese Level
- Native
- Minimum Education Level
- Bachelor's Degree
- Visa Status
- Japanese national or permission to work in Japan required
Job Description
・ 製造受託業者との折衝・調整
・ 製造販売業者として、製造を委託している各業者とフランス本社との調整業務
・ 薬事生産動態統計調査
・ 医薬品の新規申請・一変申請(同一性調査、キット製品申請含む)
・ 生データチェックに関する及び行政対応
・ 医薬品の外国製造認定申請及び行政対応
・ 医薬品のGMP適合性調査申請及び行政対応
Required Skills
・ 年齢不問
・ 薬剤師免許証の保有者
・ 品質保証に関しても精通していること
・ 安全管理業務にも知識を有することが望ましい
・ 各種申請通知、日本薬局方、製造指針等に精通していること
・ EP 及び USPに精通しているとなお良い
・ 医薬品の開発に係る各種規制に精通していること(特にキット品)
・ キット製品の薬価に精通していること
・ 製剤分析に精通していること
・ プラスチック成形技術の基本がわかっているとなお良い
・ ビジネスレベルの英語力
Company Description
Way Simmons Partnership has offices in Tokyo, Hong Kong and Singapore and provides contingency, advertised and search solutions across the commerce and industry sector. Our recruitment business is categorised as specialist/professional. With many years of experience in search and selection our team of expert recruitment consultants has experience in the following areas:
Executive & Management
Accounting & Finance
Human Resources
Marketing & Sales
Executive Support
We act for Multinational Companies (MNCs), Small to Medium Enterprises (SMEs) and locally grown diversified businesses and employers of choice who understand the value of working in partnership with a totally focused approach to human resource solutions.
All our consultants are able to rapidly understand their clients’ hiring requirements whilst developing a strong relationship of trust with their candidates. Our team prides itself on carrying out their work with the utmost confidentially and integrity and for candidates, there is no charge for the services that we provide.
Way Simmons Partnership is a division of Legal Futures Japan K.K.
Our recruitment business is categorized as specialist/professional and our placements are limited to Japan only. Our service is free of charge. We will apply and follow the laws and principles of all relevant legislation and maintain data privacy at all times. Please refer to www.legalfutures.com to view our Privacy Policy. The person handling personal information is our license holder Matt Anderson who will also handle any complaints.
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