Prepare, review, and submit Marketing Authorization Applications (MAA) to UK MHRA.
Lead the preparation and review of CTD/eCTD dossiers for current product registrations.
Ensure compliance with current UK MHRA guidelines and regulatory requirements.
Required Candidate profile
Draft, review, and coordinate responses to UK MHRA Requests for Information (RFI) within regulatory timelines.
Coordinate with CMC, R&D;, QA, QC, Production, Packaging