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| 部署・役職名 | Regulatory Affairs Manager － Advanced Surgical |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Overview: Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more countries. Typically, will supervise or mentor more junior employees. Key Responsibilities: ● Develop and execute regulatory strategies/ plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations ● Lead the RA function on assigned cross－functional project teams ● Monitor applicable regulatory requirements; assure compliance with the company and external standards ● Establish appropriate communication within RA and other functions at the project level and to senior management ● Perform gap analysis and propose solutions ● Develop and document sound regulatory decisions and justifications ● Ensure project teams, business objectives and deliverables, and regulatory strategy are aligned ● May provide direct supervision of individuals ● May review promotional material or SOP’s for compliance with local and global regulations |
| 応募資格 |
【必須（MUST）】 Qualifications:● Sound basis of Regulatory knowledge in general ● Experience in creating and managing Class IV device submissions ● Sound basis of Regulatory knowledge in country of interest ● Scientific Knowledge – ability to understand Advanced Surgery products and uses ● Ability to manage complex projects and timelines in a matrix team environment ● Strong oral and written communication and presentation skills – ability to work closely and effectively with the Global RA and project teams. ● Demonstrated interpersonal skills including strong negotiation skills ● Ability to independently identify compliance risks and escalate when necessary ● Ability to lead and coach others – internal and external partners Education ＆ Experience: ● Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 10 years regulatory experience in RA or related field, including managing people or projects. ● Higher degree/PhD will be an advantage. Ability to communicate effectively using Japanese and English. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/01/30 |
| 求人番号 | 3251218 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です