Regulatory Affairs Officer (Panchkula)

Regulatory Affairs Officer (Panchkula)

01 Aug
|
Important Group
|
Panchkula

01 Aug

Important Group

Panchkula

- 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)
🏢 Important Group
📍 Panchkula

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