【英語を活かす】薬事シニアマネージャー/ Regulatory Affairs Senior Manager Pioneering pharmaceutical companyの転職・求人情報 28701505

募集要項

募集背景: A pioneering pharmaceutical company is looking for a Regulatory Affairs Senior Manager. The selected candidate will work with global teams to define regulatory strategies and manage the submission of regulatory documents.

仕事内容: A pioneering pharmaceutical company is looking for a Regulatory Affairs Senior Manager.
Responsibilities:

* Define development and regulatory strategy with local and global teams
* Lead or support regulatory and CRO activities for specific products
* Provide strategic regulatory advice as a member of global regulatory teams
* Coordinate and respond to regulatory authorities' inquiries within strict deadlines
* Maintain and organise regulatory files per internal standards
* Review and recommend changes to regulatory documentation and processes

Requirements:

* Bachelor's degree or above (advanced science or healthcare degree is a plus)
* More than 5 years of experience in regulatory affairs and clinical development role
* Experience in interpretation of guidelines
* Prior experience with regulatory filings (electronic submissions)
* Knowledge of regulations
* Excellent technical system skills
* Native level Japanese; business level English

応募資格

必須: More than 5 years of experience in regulatory affairs and clinical development role

事業内容・会社の特長: A pioneering pharmaceutical company focused on advancing innovative therapeutic solutions. Committed to scientific excellence, it aims to improve patient outcomes through cutting-edge research and development.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

2094470/001