Company: Ambic Healthcare LLP
We Are Hiring – Regulatory Affairs Executive (1–3Years)
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 prospect 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
Solid documentation & communication skills
MS Office proficiency (Excel/Word/PPT)
Attention to detail and ability to meet timelines
Positive attitude, analytical mindset & teamwork abilities