Job Purpose:

To support plant-level regulatory activities by coordinating regulatory documentation, dossier support, compliance assessments, artwork approvals, and regulatory submissions for US, EU, Canada, and Emerging Markets.

Key Responsibilities:

- Coordinate with cross-functional teams to collect and compile documents for regulatory dossiers and submissions.
- Prepare and support responses to regulatory authority queries.
- Manage applications for NOC, PP, COPP, FSC, Test Licenses, and other regulatory approvals.
- Review and approve product artworks for regulatory compliance.
- Review CMC sections of dossiers for accuracy, completeness, and compliance.
- Conduct regulatory impact assessments for Change Controls and recommend filing strategies.
- Maintain and manage regulatory documentation and submission records.
- Review APQR, NIRA, and EIRA from a regulatory compliance perspective.




- Liaise with Corporate Regulatory Affairs and internal stakeholders for regulatory activities.
- Support audits, inspections, and customer queries by providing regulatory documentation and inputs.

Qualification & Experience:

- B.Pharm / M.Pharm or equivalent Life Sciences qualification.
- 2-5 years of experience in Plant Regulatory Affairs within the pharmaceutical industry.

Key Skills:

- Knowledge of regulatory requirements for US, EU, Canada, and Emerging Markets.
- Understanding of CTD/eCTD dossiers and CMC documentation.
- Regulatory compliance, change control assessment, and artwork review.
- Solid documentation, communication, and cross-functional coordination skills.

📌 Regulatory Affairs Officer (Sanand)
🏢 Emcure Pharmaceuticals
📍 Sanand