Regulatory Affairs Officer

4 days ago


Panchkula, India TalentXplore Full time

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.

**Job Types**: Full-time, Permanent

Pay: ₹400,000.00 - ₹600,000.00 per year

Schedule:

- Day shift

Work Location: In person



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