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Manager / Senior Manager

Manager / Senior Manager

Celon

10 - 15 years

10 - 18 Lacs

Hyderabad

Posted:21 hours ago| Platform:

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Skills Required

Drug Regulatory Affairs Regulatory Affairs Dossier Preparation Dossier Product Registration

Work Mode

Work from Office

Job Type

Full Time

Job Description

1. Regulatory Submissions:

Preparation and compilation of dossiers in CTD/eCTD formats for domestic and international markets (ROW countries).
Submission of registration applications for new products and variations (post-approval changes).

2. Documentation:

Review and verification of technical documents such as Product Information Leaflets, Labels, SPC, COAs, Stability Data, Product Development Reports, etc.
Coordination with R&D, QA, QC, and production teams for required documents and data.

3. Regulatory Compliance:

Ensure products and documentation comply with applicable regulations and guidelines (ICH, WHO, FDA, EMA, CDSCO, etc.).
Monitor regulatory changes and ensure timely updates to internal systems and processes.

4. Product Lifecycle Management:

Handle renewals, variations, and responses to regulatory queries/deficiencies.
Maintain product registration databases and archival of regulatory submissions.

5. Liaison & Communication:

Coordinate with regulatory authorities, agents, and external consultants as required.
Attend audits and respond to regulatory inspections

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