Regulatory Affairs Associate

Location
Middlesex
Salary
Negotiable
Posted
27 Nov 2018
Closes
27 Dec 2018
Ref
VR/02805
Contract Type
Contract
Our client, a globally recognised pharmaceutical company are hiring immediately and require a Senior Regulatory Affairs associate to join their established team.

Key Responsibilities:

* The Regulatory Professional under the direction of a Regional Regulatory Lead will lead compilation of CMC regulatory packages for submission and may be the lead for a program under supervision.
* Collect and / or create country specific documents for regulatory filings worldwide.
* Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead.
* Ensure compliance via timely submissions to regulatory agencies.
* Coordinate collection of functional documents in support of regulatory applications.
* Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance.


Skills/Experiences:

* Strong communication skills oral and written
* Ability to multi-task in a fast-paced environment
* Organizational skills
* Understanding of drug development process; knowledge and understanding of CMC requirements, especially country specific documents for international filings
* Familiarity with Document Management Systems.


Regulatory Affairs, Regulatory, CTA, MA, CMC, Submissions, Regulatory Associate, Regulatory Submissions

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