Company: Ambic Healthcare LLP We Are Hiring – Regulatory Affairs Executive (1–2Years)

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 chance 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
• Support in audits, GMP documentation & client/authority queries
• Stay updated with ICH/CDSCO/WHO/FDA/EMA/MOH guidelines 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

📌 Regulatory Affairs Executive (Mumbai)
🏢 AMBIX HEALTHCARE
📍 Mumbai