Drug Regulatory Affairs (Baddi)

Drug Regulatory Affairs (Baddi)

21 Aug
|
Maya Biotech
|
Baddi

21 Aug

Maya Biotech

Baddi

To support regulatory and compliance activities related to pharmaceutical products, including artwork review, product approvals, MRP verification, documentation, and dispatch compliance.

- Review and maintain regulatory dossiers and ensure that required documents are complete, accurate, updated, and aligned with the approved product details.
- Review dossier documents such as manufacturing documents, specifications, COA, stability data, validation documents, licenses, approvals, CPP/COPP, and other applicable regulatory documents.
- · Coordinate with QA, QC, Production, and other departments for collection, review, and timely completion of dossier documents.
- Review and maintain regulatory documents related to product approvals, licenses, NOCs, registrations, and other statutory requirements.
- Review and verify product artwork as per applicable regulatory guidelines, approved documents, and product specifications.
- Verify MRP and pricing details as per applicable NPPA, DPCO, NLEM and other relevant regulatory requirements.




- Verify product samples/finished packs before dispatch to clients to ensure that artwork, batch details, MRP, packing information, and other regulatory particulars are correct.
- Check product approval status and verify whether the product is DCGI/Central approved or requires State Drug Authority approval/NOC.
- Review agreements from a regulatory perspective and ensure that product, manufacturing, regulatory, and compliance-related requirements are appropriately covered.
- Coordinate with QA, Production, Artwork, Commercial, and other departments for regulatory compliance and timely closure of observations.
- Maintain proper records of regulatory approvals, artwork versions, samples, and related documentation.

Keep updated with applicable changes in D&C; Act/Rules, DPCO, NPPA, NLEM and other regulatory requirements and communicate relevant changes internally.

Perks:

- Paid time off
- Provident Fund

Work Location: In person

📌 Drug Regulatory Affairs (Baddi)
🏢 Maya Biotech
📍 Baddi

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