About the role
- 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