RA Senior Manager

Location Japan
Discipline Life Science
Job type Permanent
Salary 13,000,000
Reference 36736


One of the largest generic pharmaceutical companies in the world with global revenues of over 5 billion USD. They have multiple manufacturing facilities, and are providing high-quality, affordable medicines. They are trusted by healthcare professionals and patients, in more than 100 countries around the world.



- Applying for approval of new drugs and generic drugs, responding to reviews, and obtaining approval.

- Formulation of regulatory affairs strategies at the development stage.

- Coordination of the project team in PMDA consultations.

- Contact point for new applications, compilation of approval application materials, preparation of fixed

deposit application forms.

- Leading the planning and finalization of pharmaceutical strategies for clinical trials and approval


- Appropriate notification and education of Japanese pharmaceutical regulations to overseas

development departments.



- Bachelor's degree or above (bachelor's degree related to life science such as chemistry, pharmacy, etc. is


- More than 10 years’ experience in at a pharmaceutical company with More than 5 years of experience in

new drug development regulatory affairs.

- Experience leading new drug or generic drug applications.

- Business-level English skills required.