Description
Major Duties:* Provide submission strategy for execution of lifecycle submissions associated to management of CMC changes originating at manufacturing sites or PCO's toward maximizing efficiency, quality and rate of submission approvals by BoH.
* Provide regional/local management of lifecycle submissions in markets under responsibility, including: Market Application amendments, variations, renewals, supplemental submissions.
* Coordinate with the Regulatory Process & Systems Support and Publishing team for the generation of the submission ready components required to support lifecycle 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.
* Manage timely responses to Board of Health questions resulting from lifecycle submissions in markets under responsibility.
* Compliance with Department and Company Standard Operating Procedures (SOP's) relevant to the position.
* Assist PCO's Regulatory Affairs staff with other regulatory activities as needed.
* Interaction with plants, PCO's, and Division personnel in relation to regional regulatory conformance activities.
Qualifications
Essential Criteria for the role:
* 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 this role is of interest and you would like to discuss it further then please contact Peter Duvall at Real Staffing on
To find out more about Real please visit www.realstaffing.com