※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] Regulatory Affairs CMC Associate Director
[Salary] 10〜17 million JPY ※Experiences and skills will be considered
Associate Director, Regulatory Affairs is responsible for overall pharmaceutical affairs associated with obtaining pharmaceutical product approval. The duties include complying with Japan pharmaceutical affairs act, develop in good relations with the regulatory authority, and performing pharmaceutical tasks required for product development in a timely and appropriate manner.
You will be responsible for:
- Serving as a contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departments and regulatory authority.
- Performs pharmaceutical regulatory affairs tasks for obtaining pharmaceutical product approval.
- Prepares various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.
- Manages pharmaceutical regulatory affairs schedules for product development plan.
- Working with internal concerned departments, prepares appendices attached to pharmaceutical regulatory affairs documents to be submitted to regulatory authority and submits them.
- Negotiates with subcontractors and external parties about pharmaceutical affairs issues as needed.
- Working collaboratively with other departments, reviews the documents (minutes, examination report, etc.) created by regulatory authority, builds a consensus and confirm them with the regulatory authority and obtains the final version of the documents.
- Presents pharmaceutical affairs strategies for product development plan to the concerned departments and gains consensus from them.
- Support Director's job
- Minimum 5-10 years work experience in RA including more than 3 products approval experience as JRA leader
[Preferred Knowledge, Skills and Abilities]
- MS or equivalent
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Director
Job Function: Health Care Provider