22 Aug
|
maya biotech private
|
Baddi
22 Aug
maya biotech private
Baddi
Are you an experienced Drug Regulatory Affairs professional looking to take the next step in your pharmaceutical career?
We’re looking for a detail-oriented and regulatory-focused professional to join our Regulatory Affairs team as a DRA Executive.
? Location: Baddi / Chandigarh
? Department: Regulatory Affairs
? Designation: DRA Executive
? Reporting To: Regulatory Affairs Manager / Head – Regulatory Affairs
? Qualification: B.Pharm / M.Pharm
⏳ Experience: 4–6 years in Pharmaceutical Drug Regulatory Affairs
? What You’ll Be Responsible For
As a DRA Executive, you will play an key role in ensuring that our products and documentation remain regulatory-compliant, accurate, and ready for approval and dispatch.
Your key responsibilities will include:
• Managing and reviewing regulatory dossiers and ensuring completeness, accuracy, and alignment with approved product details.
• Reviewing critical regulatory documents including manufacturing documents, specifications, COA, stability data, validation documents, licenses, approvals, CPP/COPP, and other applicable documents.
• Coordinating with QA, QC, Production, Artwork, Commercial, and other teams to ensure timely completion of regulatory documentation.
• Reviewing and maintaining documentation related to product approvals, licenses, registrations, NOCs, and statutory requirements.
• Reviewing product artwork, labels, packing materials, and regulatory particulars against approved documents and applicable guidelines.
• Verifying MRP and pricing requirements in accordance with NPPA, DPCO, NLEM, and other applicable regulations.
• Reviewing finished product packs/samples before dispatch to ensure correctness of artwork, batch details, MRP, packing information, and regulatory declarations.
• Assessing product approval requirements, including DCGI/Central approvals and State Drug Authority approvals/NOCs.
• Reviewing agreements from a regulatory perspective and ensuring appropriate product, manufacturing, and compliance
📌 DRA Executive – Regulatory Affairs (Baddi)
🏢 maya biotech private
📍 Baddi