Regulatory Affairs Officer

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.
• Strong documentation, communication, and cross-functional coordination skills.