24 Aug
|
maya biotech private
|
Baddi
24 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 important 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 requirements are covered.
• Monitoring regulatory changes related to the Drugs & Cosmetics Act/Rules, DPCO, NPPA, NLEM , and other applicable requirements.
? Who We’re Looking For
We’re looking for someone who brings:
✅ B.Pharm / M.Pharm qualification
✅ 4–6 years of relevant DRA experience in the pharmaceutical industry
✅ Strong knowledge of regulatory documentation and product approvals
✅ Hands-on experience in artwork review and regulatory compliance
✅ Robust attention to detail and documentation skills
✅ Ability to coordinate effectively with cross-functional teams
✅ A proactive approach toward regulatory updates and compliance
? Why This Role?
This is an opportunity to work across key areas of pharmaceutical regulatory affairs , from dossier management and product approvals to artwork, pricing compliance, and finished-product verification.
If you are passionate about regulatory compliance and pharmaceutical quality and want to grow your career in a dynamic Regulatory Affairs environment, we’d love to hear from you!
? Interested candidates can share their CV / apply for the position.
#Hiring #DrugRegulatoryAffairs #DRA #RegulatoryAffairs #PharmaJobs #PharmaceuticalJobs #BaddiJobs #ChandigarhJobs #PharmaHiring #RegulatoryCompliance #PharmaCareers #BPharm #MPharm #HiringNow
📌 DRA Executive – Regulatory Affairs (Baddi)
🏢 maya biotech private
📍 Baddi