Back Office Executive (CDSCO)

Role & responsibilities

• Prepare and compile documents required for CDSCO applications and licences. Coordinate with internal teams, clients, and external stakeholders.
• Handle online filing and submissions through relevant CDSCO/SUGAM portals.
• Prepare and maintain application forms, checklists, declarations, undertakings, and supporting documents.
• Coordinate with clients to collect and verify required documents.
• Review documents for completeness, accuracy, consistency, and regulatory compliance.
• Track application status and follow up on queries, deficiencies, and clarifications raised by regulatory authorities.
• Prepare responses to CDSCO queries in coordination with the regulatory team.
• Maintain proper records of submitted applications, licences, approvals, and correspondence.
• Coordinate with the internal regulatory and sales teams for timely completion of applications.
• Stay updated on changes in CDSCO rules, forms, guidelines, and regulatory requirements.

Preferred candidate profile

• Good knowledge of CDSCO, Drugs & Cosmetics Act/Rules, Medical Devices Rules, and Cosmetics Rules.
• Good knowledge of MS Office, especially Word and Excel.
• Strong documentation and data-entry skills.
• Excellent attention to detail.
• Good written and verbal communication skills.
• Ability to manage multiple applications and meet deadlines.
• Ability to work independently as well as in a team.