Regulatory Affairs Specialist cmc biologics

Beschreibung

Regulatory Affairs Specialist CMC biologics - 10 months contract

Major Accountabilities
* Author global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
* Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
* coordinate management of documentation needed for direct submission to Health Authorities.
* Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
* Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.

Experience:
* Experience in regulatory affairs in CMC area in the pharmaceutical industry
* Knowledge and experience of regulations, guidelines and product life cycle maintenance
* Ability to critically evaluate data from a broad range of scientific disciplines.
Knowledge of the drug development process

Michael Bailey International is acting as an Employment Business in relation to this vacancy.