Job Responsibilities

- Prepare, compile, and maintain regulatory documents and submissions.
- Support preparation of dossiers, applications, and regulatory documentation for pharmaceutical products.
- Coordinate with QA, QC, Production, R&D;, and other departments for required regulatory information.
- Review documents for completeness, accuracy, and compliance with regulatory requirements.
- Maintain regulatory files, records, product registrations, and approvals.
- Assist in preparation and submission of variations, renewals, amendments, and other regulatory updates.
- Track submission status, approvals, queries, and regulatory timelines.
- Support responses to regulatory authority queries under the guidance of senior team members.
- Maintain regulatory databases and ensure documents are properly updated.




- Stay updated on applicable regulatory guidelines and requirements.
- Assist in preparation of documents required for audits and inspections.
- Required Qualification
- B.Pharm / M.Pharm or equivalent pharmaceutical qualification.
- 1–2 years of experience in Regulatory Affairs in the pharmaceutical industry.
- Basic knowledge of pharmaceutical regulatory requirements and documentation.
- Valuable documentation, communication, coordination, and MS Office skills.

Pay: ₹15,000.00 - ₹25,000.00 per month

Benefits:

- Flexible schedule
- Paid sick time
- Paid time off
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Officer (India)
🏢 BRIX BIOPHARMA
📍 India