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
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.