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

Perks:
Versatile schedule
Paid sick time
Paid time off
Provident Fund

Work Location: In person

📌 Regulatory Affairs Officer Maharashtra
🏢 BRIX BIOPHARMA
📍 Maharashtra