Company: Ambix 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.
- 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.
Pay: ₹12,000.00 - ₹35,000.00 per month
Benefits:
Work Location: In person
