DRA Executive – Regulatory Affairs
Maya Biotech Private Limited · Baddi, Himachal Pradesh, India
Apply & track with Apply EdgeAre 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 ForAs 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 ForWe’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✅ Strong 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