レギュラトリーストラテジスト/ Regulatory Strategist
求人保存
給与 ¥10,000,000 - ¥12,000,000 per annum
勤務地 Tokyo
FULL_TIME担当コンサルタント James Kang
求人番号 1614470/001
掲載日 2022/08/04
kanto healthcare/regulatory-affairs 2022-08-05 2022-10-03 medical-and-nursing Tokyo Tokyo JP JPY 10000000 12000000 12000000 YEAR Robert Walters https://www.robertwalters.co.jp https://www.robertwalters.co.jp/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
A global distributor of medical products is looking for a Regulatory Strategist. The chosen applicant will be responsible for developing strategies to efficiently obtain approval for new products.
Responsibilities:
- Work closely with relevant teams to prepare documents for submission to PMDA and MHLW
- Organise the necessary documents for NDA submission
- Ensure documents for health authorities are arranged by other business functions
- Participate in global regulatory projects
- Provide legal requirements and development strategies to global regulatory team as needed
- Understand regulatory requirements and NDA guidelines
Requirements:
- Bachelor’s degree or above
- 5+ years of experience in a similar role
- Negotiation experience with PMDA
- MS Office skills
- Excellent collaboration and communication skills
- Business level English (TOEIC 730+), fluent level Japanese
About the Company:
A multinational pharmaceutical organisation originating out of Europe that is responsible for the research and development of several widely recognised pharmaceutical products as well as products related to diagnostic imaging, women’s health and adhesives among others.
Keywords:
バイオ製薬, 製薬, 製薬業界, 医薬品, 生医学, ライフサイエンス, 生命科学, 医療, メディカル, ヘルスケア, 医療機器, 求人, 外資系
1614470/001
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