Manager RA TA Group Regulatory Affairs
Manager RA TA Group Regulatory Affairs
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Job Description
Major Responsibilities:
TA: Oncology
- 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 Oncology is preferable.
- Must have pharmaceutical experience
:
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our shortterm incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
