投稿日：2024/03/10
（社名非公開）
RA Manager / Diabetes Care（糖尿病関連）
ポジション情報
| 職種 | 薬事申請 |
|---|---|
| 雇用形態 | 正社員（期間の定め無し） |
| 勤務地 | 東京都 |
| 給与 | 800万円～1350万円 |
| 給与（詳細） | 経験・スキルに応じて優遇 |
| 職務内容 | ○Develop best-in-class submission strategy. ○Assess the acceptability of quality, preclinical and clinical documentation for submission filing. ○Negotiate and interact with PMDA and MHLW during the development and review process to ensure submission approval. ○Build positive relationships with authorities. ○Monitor and submit applicable reports and responses to regulatory authorities. ○Monitor impact of changing regulations on submission strategies and update internal stakeholders. ○Provide regulatory input for and appropriate follow-up to inspections and audits. ○Provide regulatory input for product recalls and recall communications. ○Review and assess external documents/communications relative to regulations. ○Strategize with and advise internal stakeholders on regulatory issues and requirements. ○Provide training for stakeholders on regulatory requirements including safety related operations to ensure company-wide compliance. ○If required, attend meetings of the industrial activities and express the opinions of embecta. |
| 応募資格 | ○Extensive knowledge and experience of Japan regulatory ○Expertise in creating Japan regulatory strategies and ensuring timely and high-quality submission of medical device product registrations. ○Established relationships with PMDA and MHLW. ○Working experience for regulatory submission. ○Strong interaction with regional/global organizations. ○Strong interaction with sales, marketing, and other functional areas. ○Other functional expertise such as QA, R&D, etc. ○Professional Skills & Key Competencies ○Effective communication in both English and Japanese. ○Adaptable with positive energy and enthusiasm to work in a start-up company. ○Flexible to work on challenges and unprecedent issues. ○Proactive collaboration with various functional groups and individuals with conflicted interest. ○Mid and long -term business planning mindset with strategic thinking. |
企業情報
| 募集企業 | （社名非公開） |
|---|
