Description
Job Title - Regulatory Affairs Executive12 month contract - Paid hourly
Location -Surrey
Key Responsibilities:
* Provide regional/local management of lifecycle submissions in markets under responsibility,
Including: Market Application amendments, variations, renewals, supplemental submissions.
* Assemble lifecycle submissions for markets under responsibility and coordinate with PCO's for timely and effective submission of changes to the Boards of Health.
* Ensure that the CMC change management electronic systems are updated and maintained in alignment with the regulatory information submitted/approved externally by a Board of Health or internally by the appropriate functional area.
* Compliance with Department and Company Standard Operating Procedures (SOP's) relevant to the position.
Qualifications
* Bachelor's degree or equivalent qualifications in Chemistry, Pharmacy or a related life science field.
* Experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or
Compliance.
* Strong knowledge / background of Regional CMC.
* Experience with CMC submissions
If you are interested in this position call Mina on
To find out more about Real please visit www.realstaffing.com