Back Office Executive (CDSCO)

Talent Corner Hr Services; New Delhi; On-site; INR 400,000 - 800,000; Full time

Job summary

Talent Corner Hr Services in Delhi seeks a CDSCO regulatory documents executive to prepare and compile documents for CDSCO applications and licences, coordinating with clients and internal teams to ensure accuracy and compliance.

You will handle online filing, maintain forms and checklists, verify documents, track status, and respond to queries from authorities, while keeping records up to date and aligning with regulatory changes.

Qualifications

• 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.

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.

Skills

Attention to detail

Documentation

Data-entry

Written communication

Verbal communication

Time management

Tools

MS Word

MS Excel

Job description

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.