募集要項
- 募集背景
- The Regulatory Affairs Director combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual will develop, actively mentor and supervise the regulatory team
- 仕事内容
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Regulatory Affairs Director of a leading global Medical company<Responsibilities>
* Lead and develop Regulatory Strategic planning, present external regulatory landscape intelligence on the engagement of external trading association. Oversee regulatory aspects of regulatory body relationships to ensure compliance and protect corporate interests
* Lead, guide and mentor both Japan and APAC RA staff. Develop organization for future capabilities
* On-time submission and approval of best-in-class regulatory documentation (including new product submissions/indication expansion, and deficiency responses); analysis and identification of regulatory requirements against project needs including reimbursement requirements, maintaining annual licenses, registrations, and listings
* Support advocacy with scientific/ academic institutions in alignment with Regulatory Strategy to promote the division in collaboration with Medical Affairs and other cross functions
* Manage and develop teams. Formulate company procedures to respond to regulatory authority queries
* Review product claims and preserve confidentiality of applicable product information. Review and approve advertising and promotional items to ensure regulatory compliance
* Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle and develop future strategies and actions
* Provide regulatory input for follow-up to inspections and audits to ensure compliance with product post-marketing approval requirements
Real is part of the larger SThree K.K group
To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com
Award winner of:
Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018
- 応募資格
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- 必須
- The Regulatory Affairs Director combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
- フィットする人物像
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<Requirements>
* A minimum of 10 years prior experience in Regulatory, R&D, Medical, Quality or related area, preferably in medical devices
* Experience interfacing with government regulatory agencies (PMDA, MHLW) and proven skill at developing and implementing successful regulatory strategies for product launched in the Japan market
* Bachelor's degree or equivalent
* Business level English and Japanese
* Familiarity with medical device industry policies, operations, and procedures
* PC skills(Microsoft Office)
* Track record in working closely with Government Affairs, Medical and Market
* Masters/PhD Degree preferred. Degrees in Scientific Discipline (biology, chemistry, medical technology, pharmacy, pharmacology, math, engineering, or medical fields) preferred
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY20,000,000.00 - JPY22,000,000.00 per annum + competitive
