Regulatory Affairs Officer

Norega International; Delhi; On-site; INR 420,000 - 620,000; Full time

Job summary

Norega International is seeking a Regulatory Affairs professional in Delhi to prepare dossiers for domestic submissions to CDSCO. The role involves coordinating cross-functional teams to ensure timely submissions and maintaining meticulous records of regulatory correspondences and updates.

The candidate should have 1–3 years of experience in Drug Regulatory Affairs or Medical Devices Domestic Regulatory Submission, with a B.Pharma degree and preference for relevant certifications.

Qualifications

• 1-3 years of experience in Drug Regulatory Affairs or Medical Devices Domestic Regulatory Submission.
• B.Pharma degree required; relevant certification preferred.
• Strong understanding of dossier preparation, drug registration domestic submissions, medical devices regulations.

Responsibilities

• Prepare dossiers for domestic registration submissions to CDSCO, including compilation of data from various sources.
• Coordinate with cross-functional teams to ensure timely submission of documents and reports.
• Maintain accurate records of all regulatory correspondences, meetings, and updates.
• Ensure compliance with regulatory requirements by reviewing documentation and providing feedback on quality control issues.
• Collaborate with internal stakeholders to resolve queries related to drug regulatory affairs.

Skills

Dossier preparation

Regulatory affairs

Cross-functional coordination

Education

B.Pharma degree

Job description

Roles and Responsibilities

• Prepare dossiers for domestic registration submissions to CDSCO, including compilation of data from various sources.
• Coordinate with cross-functional teams to ensure timely submission of documents and reports.
• Maintain accurate records of all regulatory correspondences, meetings, and updates.
• Ensure compliance with regulatory requirements by reviewing documentation and providing feedback on quality control issues.
• Collaborate with internal stakeholders to resolve queries related to drug regulatory affairs.

Desired Candidate Profile

• 1-3 years of experience in Drug Regulatory Affairs or Medical Devices Domestic Regulatory Submission.
• B.Pharma degree required; relevant certification preferred.
• Strong understanding of dossier preparation, drug registration domestic submissions, medical devices regulations.