PIL (Pharma India Limited) is a leading pharmaceutical company with a strong global presence, specializing in high-quality generic medicines. With a commitment to innovation and compliance, PIL operates in multiple international markets, ensuring adherence to WHO, EU, USFDA, and other regulatory standards.
Key Responsibilities
- Global Product Registration:ย Prepare and submit regulatory dossiers for international markets (ROW, EU, US, etc.).
- Lifecycle Management:ย Handle post-approval variations, renewals, and updates for existing products.
- Dossier Compilation & Maintenance:ย Ensure all regulatory documents (CMC, stability, clinical data) are up-to-date.
- Regulatory Compliance:ย Monitor and implement changes in global regulatory guidelines (WHO, ICH, etc.).
- Documentation & Labeling:ย Draft and review Product Information Leaflets (PILs), SmPCs, and artworks as per country-specific requirements.
- Legal & Certification Submissions:ย Apply for Certificates of Pharmaceutical Product (CoPP), Free Sale Certificates (FSC), and WHO-GMP approvals.
- Regulatory Database Management:ย Maintain a real-time tracking system for submissions and approvals.
Eligibility Criteria
โ Education: B.Pharm / M.Pharm (Pharmaceutical Sciences preferred)
โ Experience: 4-5 years in Regulatory Affairs (DRA) with exposure to international markets
โ Skills Required:
- Strong knowledge ofย regulatory guidelines (WHO, EU, USFDA, ICH)
- Expertise inย CMC documentation & dossier preparation
- Excellent communication & project management skills
- Proficiency inย regulatory databases & tracking tools
How to Apply?
๐ฉย Send Your Updated CV to:ย regulatory@pilindia.in