Job description
Assist in the preparation and review of regulatory dossiers in CTD/eCTD format for submission. Support in the compilation of documentation for New Marketing Authorizations, Post-Approval Variations, and Renewals. Coordinate with departments such as QA, QC, Production, R&D, and Packaging for data collation and timely submission.
Review and verify product labeling, SmPCs (Summary of Product Characteristics) and artworks as per MHRA requirements. Track and manage regulatory submission timelines and maintain regulatory submission records. Assist in compiling response packages for deficiency letters / queries from MHRA. Support audits and inspections by MHRA by providing required regulatory documentation.
Maintain awareness of changes in regulatory guidelines and communicate updates internally