Development Regulatory Affairs Managerの転職・求人情報 28661402

募集要項

仕事内容: Development Regulatory Affairs Manager, individual contributor role
Group Purpose:
Facilitate patient access to company products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise for drug development; interfacing with agencies on regulators; aligning with key cross－functional partners; integrating into the company’s commercialization process, and continuously improving our processes and developing our talent.

Job Summary:
－ Conducts regulatory activities for company products in Japan
－ Support drug development or commercialization activities in Japan based on the regulatory and submission strategy by serving as Japan Regulatory Lead （JRL）
－ Develop and maintains good relationship with Japanese Health Authorities to facilitate drug approvals.
－ Provide regulatory guidance and supports various internal teams by involving Japan Development Team and Global Regulatory Team.

応募資格

必須: Knowledge And Skills
－ Over 10 years experiences in pharmaceutical industry including at least 5 years experiences in regulatory affairs with experiences conducting PMDA consultations and CTN submission in Japan.
－ Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
－ Independently develops solutions that are thorough, practical and consistent with functional objectives
－ Ability to understand scientific/clinical information
－ Organizational, communication and time management skills needed to manage multiple assignments and processes
－ Communication skills in English
－ Native level Japanese
－ Computer skills
－ Bachelors in scientific discipline

歓迎: Preferred
－ More than 5 years experiences in development regulatory affairs working on oncology/hematology drugs.
－ TOEIC score ≥780, desirable
－ Advanced degree preferred.

事業内容・会社の特長: One of the most innovative pharmaceutical companies that harnesses the best of biology and technology, use technology and human genetic data to push beyond what's known today to fight the world's toughest diseases, and make people's lives easier, fuller and longer.