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| 部署・役職名 | Group Manager － Regulatory Affairs |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Overview: Pipeline and On－Market Products Development and Maintenance from Regulatory perspectives ● Responsible and accountable for new product introduction and sustain product operation activity. ● Plan and execute necessary activities relating to medical devices and drugs. ● Manage regulatory activities relating to specific portfolio of products/projects Key Responsibilities: Report to Head of QARA Registration and maintenance of Medical Devices and Drug ● Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of regulatory files for existing marketed products ● Identify ＆ prioritize key areas of risk, and develop ＆ implement appropriate mitigation plans ● Establish appropriate communication within RA, with global Marketing, and with other functions at project level and favor proactive communication ● Ensure Registration strategy and deliverables are aligned with project teams and business objectives ● Lead regulatory activities related to their portfolio of products ● Prepare, review, and approve labeling, J－CTD based on global dossier and in cooperation with PV/MDS and confirm sufficiency of total submission dossier package for approval ● Represent or lead the RA function on assigned cross－functional project teams ● May participate external advocacy activity and contribute internal environment improvement ● May provide direct supervision of individuals ● Monitor applicable regulatory documentation and propose solutions. Identify areas for improvement ● Develop and document sound regulatory decisions and justification |
| 応募資格 |
【必須（MUST）】 Skills ＆ Experiences:● Scientific （Chemical） or pharmaceutical background as well as regulatory knowledge （at least BA）. Masters and/or PhD will be advantage. ● Experience of medical device registration （minimum 5 years）. ● Experience of pharmaceutical drug filing （supportive activities would be acceptable）. ● Management skills. ● Experience to prepare CTD Quality part （CMC RA） ● Demonstrated interpersonal skills including negotiation skills ● Ability to multitask and prioritize ● Establish relationship with regulatory authorities ● English skills: strong written, verbal communication and presentation skills （e.g., TOEIC: above 700 or 800） ● Experience worked for foreign companies is desirable |
| 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 | 3251232 |
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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