Regulatory Affairs Executive For Domestic and Export Pharma

SSP Solutions; Kolkata District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

SSP Solutions in Kolkata is seeking a regulatory affairs professional to handle domestic regulatory submissions, licensing, ONDLS and CDSCO processes, and dossier preparation for various products.

You will coordinate with licensing authorities, ensure labelling and packaging compliance, manage CoPP applications, and oversee timely licence renewals and amendments.

Qualifications

• Experience with domestic regulatory submissions, drug licensing, ONDLS, CDSCO, CoPP applications and dossier preparation.

Responsibilities

• ONDLS portal product permissions
• Manufacturing licence amendments and product permission renewals
• Documentation review
• Coordinate with State Licensing Authorities and CDSCO
• Labelling and packaging compliance
• CoPP applications
• Dossier preparation

Skills

Regulatory submissions

Dossier preparation

Labelling compliance

Education

M. Pharma

Tools

CDSCO

OnDLS portal

Job description

• ONDLS portal product permissions
• Manufacturing licence amendments and product permission renewals
• Documentation review
• Coordinate with State Licensing Authorities and CDSCO
• Labelling and packaging compliance
• CoPP applications
• Dossier preparation

Required Candidate profile

Experience with domestic regulatory submissions, drug licensing, ONDLS, CDSCO, CoPP applications and dossier preparation

Qualification M. Pharma