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Senior Associate, RA TA Group, Regulatory Affairs

Minato, Wakayama, Japan Job ID 2209577 Categorie Medical Afdeling AbbVie

Summary of Job Description: 

TA: Oncology or Neurology and Virus( depends on a experience)

The Regulatory Affairs Sr. Associate will be responsible for ensuring first time approval of 
new products and new indications for existing products through participation in local brand teams.
And will be responsible for preparation and revision of package insert (PI) in timely manner 
for appropriate use of products.

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 
・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 RA TA Lead of Regulatory Affairs and New Product Information (NPI) team of progress of 
applications and issues impacting local applications
・Assist with major submissions to register NCEs or new indications for existing products when needed 
・Maintaining 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
・Drive the discussion for Japan labeling in the JPT/submission team.
・Make closer communication with Global labeling team/ JAPAC regulatory team on labeling change 
and improve quality of labeling


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 5 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

Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
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