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
- 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.