02 Aug
|
Important Group
|
India
02 Aug
Important Group
India
Assist in the preparation and review of regulatory dossiers in CTD/eCTD format
for submission.
Support in the compilation of documentation for Current 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
📌 Regulatory Affairs Officer Panchkula (India)
🏢 Important Group
📍 India