AMBIX HEALTHCARE LLP
Website:
ambixhealthcare.com
Job details:
🚀 We Are Hiring – Regulatory Affairs Executive
📍 Location: Borivali, Mumbai[next to platform no 1]
🏢 Department: Regulatory Affairs
We are looking for a motivated and detail-oriented Regulatory Affairs Executive to join our team. If you have a background in Pharmacy or Life Sciences and are eager to grow in the global regulatory domain, this opportunity is for you!
🔹 Key Responsibilities
• Prepare CTD/ACTD dossiers and country-specific submissions for ROW markets (Africa, MENA, LATAM, CIS, Asia)
• Handle authority queries and ensure timely submission of responses
• Review packaging artworks and coordinate final approvals
• Collect & compile regulatory data (Q&Q, COAs, COPPs, stability, FPS/FPMOA, procedures)
• Coordinate with QA, QC, Production, Packaging & Development teams
• Arrange product samples and standards for registrations/renewals
• Coordinate with Licensing for COPP, FSC, and administrative documents
• Maintain regulatory trackers and ensure documentation compliance
• Stay updated with CDSCO/WHO/FDA/EMA/MOH guidelines
• Support in audits, GMP documentation & client/authority queries
🔹 Skills & Competencies
• Knowledge of CTD/ACTD formats
• Strong documentation & communication skills
• MS Office proficiency (Excel/Word/PPT)
• Attention to detail and ability to meet timelines
• Positive attitude, analytical mindset & teamwork abilities
Click on Apply to know more.