Senior Associate, RA TA Group, Regulatory Affairs (Specialty, Neurology, Eye Care)

Summary of Job Description:

The Regulatory Affairs TA will be responsible for ensuring first time approval of new products and new indications for existing products through participation in local brand teams.

Major Responsibilities:

• Develop 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
• Lead the strategic discussion to accelerate development. Based on the strategy we developed, discuss with the regulatory authorities, and prepare for the early submission
• Ensure Japan submission requirements are communicated to relevant regional and global regulatory team
• Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant
• Inform TA team manager of Regulatory Affairs and New Product Information (NPI) team of progress of applications and issues impacting local applications
• Lead major submissions to register NCEs or new indications for existing products when needed
• Lead new product labeling development to achieve the target product profile and post marketing appropriate use of the product.  Maintain and revise current labeling timely and appropriately in accordance with Global Company Core Data Sheet comply with regulatory requirements including GVP.
• Maintain regulatory records for assigned product portfolio in compliance with local and global procedures
• Manage interactions with PMDA and MHLW and maintain a productive working relationship
• Participate in / coordinate special project assignments as determined by the Director of Regulatory Affairs
• Support to the commercialization of products through participation in local NPI brand teams

Essential Skills & Abilities:

• Ability and desire to create results
• Requires excellent written and verbal communications in Japanese and business level communications in English
• Ability to effectively work under tight deadlines and manage projects independently.
• Resourcefulness in solving problems
• Excellent people skills and an upbeat and enthusiastic attitude.

Education / Experience Required:

• • 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 autoimmune disease is preferable.
  • Must have pharmaceutical experience

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。