AbbVie Senior Associate or Specialist, Chemistry，Manufacturing and Control (CMC) Regulatory Affairs in Tokyo, Japan
Senior Associate or Specialist, Chemistry，Manufacturing and Control (CMC) Regulatory Affairs
Japan, Tokyo-To, Tokyo
Summary of Job Description:
The Regulatory Affairs Specialist will be responsible for maintaining marketed products in Japan with registration of requested itemsthrough regulatory procedures and support for CMC filing for new compounds.
•To provide filing and registration schedule to people concerned, such as Product QA and supply chain group to prepare for maintaining approval status
•To prepare application materials for partial change application and abridged new drug registration
•To interface with stakeholders, such as regulatory agencies, JD-CMC, supply chain and global CMC.
•To Help marketing authorization application on CMC part, if needed
•To monitor marketing activities and make necessary measures to comply with the relevant laws
•Maintaining regulatory records for assigned product portfolio in compliance with local and global procedures
•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:
•Potential leadership skills
•Ability and desire to create results
•Requires business-level written and verbal 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
•Around 3-5 years related CMC experience in regulatory affairs, including regulatory maintenance, Experience in the area of biologics is preferable.
•Must have pharmaceutical experience