Core Responsibilities

- Documentation & Submission: Compile, review, and submit dossiers, amendments, and renewal applications to health authorities.
- Compliance: Ensure all research, development, and commercial activities align with regulatory guidelines.
- Lifecycle Management: Monitor post-approval supplements and address regulatory agency queries.
- Cross-Functional Collaboration: Coordinate with R&D;, Quality Assurance, and marketing departments to ensure labels and manufacturing specifications are accurate.

Requirements & Qualifications

- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Experience: Typically (2) to (5) years of relevant experience in dossier compilation, ROW (Rest of World) markets, or FDA/EMA submissions.
- Skills: Solid knowledge of CMC documentation, eCTD software, and current regulatory expectations.

Pay: ₹48,000.00 - ₹55,000.00 per month

Work Location: In person

📌 Regulatory Affairs Executive (Parel)
🏢 sarah vision
📍 Parel