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: Strong knowledge of CMC documentation, eCTD software, and current regulatory expectations.
Pay: ₹48,000.00 - ₹55,000.00 per month
Work Location: In person
