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A multinational Pharmaceutical company is seeking to recruit a Regulatory CMC Conformance Manager
- Responsible for all tasks associated with managing lifecycle submissions with the company.
- The position is responsible for providing submission strategy for all registration activities within the countries under responsibility and driving all activities required for timely and effective submission and approval of changes with Boards of Health.
- Major Duties Provide submission strategy for execution of lifecycle submissions associated to management of CMC changes originating at manufacturing sites or company 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 and 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 company 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 the company’s Regulatory Affairs staff with other regulatory activities as needed.
- Interaction with plants, Company and Division personnel in relation to regional regulatory conformance activities.
- 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
- Language skills – good English speaking and writing
- Strong knowledge background of Regional CMC.
- Experience with CMC submissions
- Experience in negotiation with Regulatory Authorities Experience in AFME Region submission requirements
Language skills: Arabic