Regulatory Affairs

**Job Opening – Regulatory Affairs Executive**

📍 Location: Malad West, Mumbai

🏢 Company: Caltron Chem

💰 **Salary:** ₹20,000 – ₹28,000 per month

👨‍💼 Male/Female Candidates Can Apply

### Job Responsibilities

* Prepare, review, and submit regulatory dossiers for product registrations, renewals, and amendments.

* Handle CTD/eCTD submissions for domestic and international markets.

* Ensure compliance with CDSCO, US FDA, EU, WHO, and other regulatory guidelines.

* Coordinate with QA, QC, R&D, Production, and Supply Chain teams.

* Review labels, artworks, and packaging materials for compliance.

* Maintain regulatory documentation, approvals, and licenses.

* Track regulatory updates and implement necessary changes.

* Respond to regulatory queries and audit observations within timelines.

* Support inspections, audits, and lifecycle management activities.

### Key Skills

* Regulatory submissions (CTD/eCTD)

* Product registration and lifecycle management

* Knowledge of CDSCO, US FDA, EU, WHO, and ICH guidelines

* Documentation and compliance management

* Good communication skills and confidence

* Strong coordination and analytical skills

### Qualification

* B.Pharm / M.Pharm / Life Sciences Graduate or Postgraduate

### Preferred Candidate Profile

* 2–5 years of experience in Regulatory Affairs in a pharmaceutical company

* Experience in domestic and/or international market submissions preferred

📲 Eligible candidates may send their CV via WhatsApp: **8652090383 / 8454097057