Regulatory Affairs Executive

Key Responsibilities1. Regulatory Submissions

• Prepare, compile, and submit dossiers, CTDs/eCTDs, ANDA/NDA, site registrations, and renewals.
• File applications for product approvals, variations, stability updates, and post-approval changes.
• Assist in obtaining and maintaining necessary licenses, NOCs, and approvals from regulatory bodies (e.g., CDSCO, FDA, EMA, WHO).

2. Documentation & Compliance

• Review and validate labels, artwork, product inserts, and packaging content to ensure regulatory compliance.
• Prepare and maintain Product Information Files (PIFs), technical documents, master formulas, and SOPs.
• Ensure documents meet Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

3. Coordination With Internal Teams

• Work closely with R&D, QA/QC, Production, Packaging, Marketing, and Supply Chain teams.
• Facilitate smooth communication for data requirements, stability reports, COAs, and specifications.

4. Liaison With Regulatory Authorities

• Communicate with regulatory bodies for clarifications, deficiency responses, and queries.
• Track status of submissions and ensure timely follow-ups and approvals.

5. Change Control & Risk Management

• Manage regulatory impact assessments for formulation, packaging, or process changes.
• Support audit readiness for regulatory inspections and quality audits.

6. International Market Registration (If applicable)

• Prepare dossiers for ROW markets, semi-regulated and regulated markets.
• Stay updated on country-specific guidelines and regulatory requirements.

7. Monitoring Laws, Guidelines & Updates

• Keep track of changes in drug regulations, pharmacovigilance rules, and documentation standards.
• Update internal teams about new regulatory requirements.

Job Type: Full-time

Pay: ₹12,700.81 - ₹25,000.00 per month

Benefits:

• Provident Fund

Work Location: In person