Company OverviewPharmaceuticals Company
Job DescriptionEnsure first time approval of new products and new indications for existing products and to support a commercialization of products through participation in local brand teams.
· Lead developing local regulatory strategies and plan for major submissions to register New Chemical Entities (NCE) or new indications with Director of Regulatory Affairs and agree local submission timelines
· Ensure Japan submission requirements are communicated to relevant regional and global regulatory team
· Lead determining local Regulatory Risk for submissions and risk mitigation strategies where relevant
· Lead major submissions to register NCEs or new indications for existing products when needed
Requirements· Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical related fields is required
· More than 3 years related experience in regulatory affairs, including regulatory strategy and regulatory maintenance, from CTN submission to approval of the compounds. Experience in the area of infectious disease or autoimmune disease are preferable.
· Must have pharmaceutical experience
· Cutting-edge regulatory knowledge including CMC, non-clinical and clinical development
· Knowledge about global regulatory trend, mainly US and EMA
· Requires excellent written and verbal communications (both in English and Japanese)