Director, Regulatory Affairs Strategy
募集要項
| 年収 | 応相談 |
|---|---|
| 雇用形態 | 正社員 |
| 職種 | 前臨床研究(薬物動態) |
| 仕事内容 | At our company, you can make a difference by helping to deliver life－saving and life－ enhancing medicines to people around the world. Our commitment to this mission has resulted in our impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. 【Responsibilities/Duties】 • Collaborate closely with internal project teams in the design and development of regulatory strategies for client projects or to answer client inquiries • Collaborate with the Global Regulatory Affairs Strategy group in providing support and input for one another’s projects based on past therapeutic experience and global, regional and local regulatory expertise. • Provide the leadership and strategic direction for the regulatory affairs activities in Japan. • Collaborate closely with provide daily mentoring and guidance for local staff. • Work closely with sponsor companies and internal |
| 求める人材 | 【求める条件】 An advanced degree with a focus in the sciences is required, an MD, PhD or PharmD is preferred. • The ideal candidate will possess 10＋ years experience with increasing levels of responsibility in regulatory affairs roles and a track record of successful drug submissions and approvals in Japan. • A successful track record of developing relationships with the PMDA. • Should be acknowledged as an expert in Japan for regulatory issues facing pharmaceutical and biotech companies with the ability to translate development strategies into regulatory actions. • Capable of establishing immediate credibility with business partners as well as within the company, able to build consensus and achieve goals through influence versus direct line authority. • Thorough knowledge of regulatory requirements from Japan PMDA for the conduct of drug development programs. • Background working with multi－disciplinary teams and experience in all phases of drug development. • Outstanding communic |
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 | - |
