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薬事スペシャリスト（体外診断薬）

外資系ライフサイエンス企業にて体外診断用医薬品に関わるRAスペシャリストを募集中です。
Job Summary


Join Thermo Fisher Scientific Diagnostics K.K. as an extraordinary Regulatory Affairs Specialist II, an outstanding opportunity to contribute to our world-class Regulatory Affair team in Japan. You will be instrumental in ensuring that our innovative products and services meet the highest standards of safety and compliance, helping us make a global impact.


Job Responsibilities


  • Provide expert advice and suggestions to ensure new products, services, and activities comply strictly with national regulations.
  • Plan and successfully implement regulatory strategies based on project plans.
  • Communicate regularly with collaborators both internationally and domestically to acquire essential information for pharmaceutical applications.
  • Prepare and review registration documents and labeling materials for in vitro diagnostics and medical devices.
  • Undertake updates and changes to relevant licenses in a timely manner.
  • Consult with regulatory authorities (MHLW, PMDA, certification bodies, prefectures, public health centers) as necessary.
  • Advise on pharmaceutical strategies for clinical research, confirm data, and support ethical reviews.
  • Collaborate with QA teams to respond to QMS auditing by authorities.
  • Maintain and continuously improve processes to ensure compliance with regulatory standards.


Necessary Skills


  • Proven ability to connect effectively with Japanese and foreign peers.
  • Ability to plan multiple tasks and prioritize activities flawlessly.
  • Detailed understanding of the Pharmaceutical and Medical Devices Law.
  • Competence in accurately understanding and compiling test reports.
  • Proficiency in reading and writing English for international communication.
  • Familiarity with other essential laws and guidelines (Poisonous and Deleterious Substances Control Act, Industrial Safety and Health Act, PRTR-SDS Act, Ethical Guidelines, etc.).

詳細についてお話できます。
Ayu.Takeda@hays.co.jpまでお気軽にお問い合わせください。

求人概要

雇用形態
正社員
業界・業種
研究・開発
勤務地
東京23区内
専門分野
ライフサイエンス
参照番号
1116060

コンサルタントにご相談ください

この求人は Ayu Takeda, が担当しております。お気軽にご相談ください。, オフィス： 東京本社
〒106-6038, 東京都港区六本木1-6-1

Tel.: 03-3560-1781

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