Drug Regulatory Affairs (DRA)

Roles & Responsibilities
• Prepare and submit regulatory dossiers in ACTD and CTD formats
• Handle applications for Certificates of Pharmaceutical Product (CoPP) and Free Sale Certificates (FSC)
• Manage item approvals and brand registrations with regulatory authorities
• Draft, compile, and process No Objection Certificates (NOC) and related regulatory documentation
• Coordinate with internal departments to ensure accurate and timely regulatory submissions
• Track regulatory timelines, approvals, and compliance requirements
• Ensure documentation complies with applicable regulatory guidelines and standards

Qualification
• B.Pharm / M.Pharm

Experience
• Proven experience in a Drug Regulatory Affairs (DRA) role is mandatory

Skills
• Strong expertise in ACTD/CTD dossier preparation and submission
• Hands-on experience with CoPP, FSC, and NOC documentation
• Good understanding of pharmaceutical regulatory requirements
• Strong documentation, coordination, and follow-up skills
• Ability to manage multiple regulatory activities simultaneously

About the Company
Sarthak Biotech Private Limited is a growing pharmaceutical company based in Karnal, Haryana, engaged in the development, registration, and marketing of quality pharmaceutical products. The company focuses on regulatory compliance, efficient market approvals, and delivering reliable healthcare solutions while maintaining high quality and ethical standards.