Regulatory Affairs Manager （薬事）
募集要項
| 年収 | 800万～1600万 |
|---|---|
| 雇用形態 | 正社員 |
| 職種 | 薬事申請 |
| 仕事内容 | Regulatory Affairs Manager Role Responsibility As Regulatory Manager, you will work in Global Regulatory Affairs and form part of the EU and Asia－Pacific Regulatory team, a successful and driven team that provides consultancy for all projects globally as well as standalone contracts with clients. You will support the Regulatory Project Lead and dependent on the size of and nature of the project assigned, you may act as the Regulatory Project Lead and deal directly with the sponsor and Regulatory Agencies. Additional Responsibilities: － Effectively manage Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by our company. － Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be concerned with: Agrochemicals, Cosmetics, Foods, Medical Devices and Veterinary products. Works on a range of regulat |
| 求める人材 | 【求める条件】 － Minimum five years Pharmaceutical/CRO experience including minimum 5－7 years Regulatory Affairs experience or equivalent － Excellent written and communication skills － EU/APAC: In depth proven experience in regulatory affairs or aligned work. － Demonstrable experience within regulatory affairs, including document preparation and/or writing, clinical trials, post－licensing activities and regulatory agency interaction － Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail. 【歓迎条件】 － Good written and spoken English. － Proficient in the use of Microsoft Office. － Bachelor’s degree, or local equivalent, preferably in the sciences, or equivalent experience qualification. － Masters degree or higher preferred. |
会社情報
| 会社名 | 会社名は非公開です |
|---|---|
| 業種 | 医療用機器・医療関連 |
| 資本金 | 1000万円 |
| 従業員数 | - |
