The CMC Regulatory Specialist has the responsibility to support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. This includes supporting the registrations of our client’s products sourced from the US and/or contributing MSRAs, for both our client and contract manufacturing sites, to the global marketing affiliates. In this role, the Specialist works closely with Indianapolis regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. In addition, the Specialist maintains post-approval commitments for products supported from ISRA for both our client and contract manufacturing sites. In this role, the Specialist works closely with Indianapolis regulatory product representatives providing essential CMC commitment information and approval status in global markets as part of manufacturing change control evaluation/completion. The Specialist appropriately updates impacted regulatory documents as part of the change control process. Key customers include the ISRA Regulatory representatives, Indianapolis manufacturing sites and the CMC Regional Centers. The Regulatory Specialist is expected to provide leadership and business process knowledge to these customers along with organization skills and prioritization ability to identify, initiate and maintain global product CMC commitments for our client marketed products.
Functional and Technical Expertise:
Minimum Qualification Requirements: