PMT Nutraceuticals is hiring a Regulatory Affairs - Executive to manage regulatory compliance, dossier preparation, and product registrations across ROW markets, including Africa, APAC, LATAM, GCC, and CIS regions.
Key Responsibilities
- Ensure regulatory compliance for nutraceutical and Ayurvedic products across ROW markets.
- Prepare, compile, and manage CTD dossiers (Modules 1-5) and country-specific registration documents.
- Handle lifecycle management, variations, renewals, and responses to regulatory deficiencies.
- Review manufacturing documents and convert them into compliant regulatory formats.
- Prepare SmPC, Package Inserts, labels, and product information documents.
- Provide regulatory guidance on dosage, formulation, and preparation.
- Liaise and coordinate with regulatory authorities for product registrations and approvals.
Rest of world Market Exposure
Asia-Pacific | LATAM | GCC | Africa | Eastern Europe & CIS
Qualifications & Experience
- 2-3 years of experience in Regulatory Affairs (ROW / Africa markets preferred):
- Hands-on experience with nutraceuticals / vitamin-based products:
- Solid knowledge of CTD dossier compilation and compliance