Company: Ambix Healthcare LLP

? We Are Hiring – Regulatory Affairs Executive

? Location: Borivali W , 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
- Solid 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