Regulatory Affairs-CMC 独占求人

 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 years’ work experience in RA.