Manager RA TA Group Regulatory Affairs
Manager RA TA Group Regulatory Affairs
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Job Description
TA: Oncology
Summary of Job Description:
The Regulatory Affairs Manager will be responsible for ensuring first time approval of new products and new indications for existing products through participation in local brand teams as well as educating to his or her staffs.
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 for Roadrunner projects. Based on the strategy we developed negotiate with the regulatory authorities and prepare for the early submission.
- Lead new product labeling development to archive 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.
- 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 group manager 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
- Educate and train regulatory strategy to the staffs
Qualifications :
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:
- Bachelors 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 neuroscience eye care or infectious disease is preferable.
- Must have pharmaceutical experience
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
