【COMPANY OVERVIEW】
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.
【JOB RESPONSIBILITIES】
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 fixe deposit application forms.
Leading the planning and finalization of pharmaceutical strategies for clinical trials and approval applications.
Appropriate notification and education of Japanese pharmaceutical regulations to overseas development departments.
【REQUIREMENTS】
Bachelor's degree or above (bachelor's degree related to life science such as chemistry, pharmacy, etc. is acceptable)
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.