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 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
- 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

Pay: ₹15,000.00 - ₹35,000.00 per month

Work Location: In person

📌 Regulatory Affairs Executive (Borivali)
🏢 Ambix Healthcare
📍 Borivali