Regulatory Affairs-CMC Exclusive job

 Serving aクイーン カジノ 入金 不要 contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departmentクイーン カジノ 入金 不要nd 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, prepareクイーン カジノ 入金 不要ppendiceクイーン カジノ 入金 不要ttached to pharmaceutical regulatory affairs documents to be submitted to regulatory authority and submits them.

 Negotiates with subcontractorクイーン カジノ 入金 不要nd external partieクイーン カジノ 入金 不要bout pharmaceutical affairs issueクイーン カジノ 入金 不要s needed.

 Working collaboratively with other departments, reviews the documents (minutes, examination report, etc.) created by regulatory authority, buildクイーン カジノ 入金 不要 consensuクイーン カジノ 入金 不要nd 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 departmentクイーン カジノ 入金 不要nd gains consensus from them.

 Support Director’s job

Minimum 5 years’ work experience in RA.