Regulatory Affairs Executive

Key Responsibilities:

• Reviewed and compiled regulatory dossiers, including CTD/ACTD, Drug Master Files (DMFs), and other regulatory submissions in accordance with applicable regulatory guidelines.
• Coordinated with domestic and international manufacturers to collect technical and administrative documentation required for dossier compilation and submission to CDSCO.
• Reviewed technical documents, including product specifications, analytical methods and procedures, stability data, and Quality Control (QC) reports for pharmaceutical formulations and Active Pharmaceutical Ingredients (APIs).
• Prepared and managed regulatory documentation, including Form 40, Form 45, Form 8, Form 9, MD-15, MD-42, and documents required under Schedule D(I) and Schedule D(II).
• Liaised with CDSCO officials to facilitate regulatory submissions, respond to queries, provide periodic updates, and maintain effective regulatory relationships.
• Prepared, reviewed, and updated package inserts, patient information leaflets, product labels, and artwork to ensure compliance with Indian regulatory requirements.
• Monitored regulatory authority websites and tracked changes in regulations, guidelines, and compliance requirements to ensure timely implementation.
• Managed regulatory submissions through the CDSCO SUGAM Portal, including application filing, query responses, and follow-up activities within prescribed timelines.
• Handled import registration of APIs, intermediates, excipients, biological products, and medical devices in compliance with Indian regulatory requirements.
• Conducted regular follow-ups and visits to CDSCO to support regulatory submissions, approvals, and ongoing compliance activities.

Interested candidate can send resume to email : kamal@sinopharmintl.com

Experience: 2-5 Years
Location: Saket, New Delhi