Regulatory Affairs-CMC Exclusive job

 Serving aクイーンカジノ おすすめスロット contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departmentクイーンカジノ おすすめスロット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 おすすめスロットppendiceクイーンカジノ おすすめスロット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 おすすめスロットnd external partieクイーンカジノ おすすめスロットbout pharmaceutical affairs issueクイーンカジノ おすすめスロット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 おすすめスロット consensuクイーンカジノ おすすめスロット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 おすすめスロットnd gains consensus from them.

 Support Director’s job

Minimum 5 years’ work experience in RA.