Regulatory Affairs

Role & Responsibilities
• Prepare and submit regulatory dossiers for assigned global markets
• Manage product lifecycle activities including variations and renewals
• Handle authority queries and regulatory responses within timelines
• Coordinate with cross-functional internal teams and external consultants
• Review artwork and mock-ups as per regional regulatory requirements
• Ensure compliance with country-specific regulatory guidelines

Qualification
• M.Pharm

Experience
• 6–15 years of experience in Regulatory Affairs
• Experience across one or more global markets: Europe, South Africa, Canada

Skills
• Regulatory dossier submission and lifecycle management
• Strong knowledge of CTD and eCTD formats
• Regulatory compliance and authority interactions
• Cross-functional coordination and communication skills
• Market-specific regulatory knowledge

About the Company
• A pharmaceutical organization engaged in global drug registration and regulatory compliance Focused on international markets including Europe, South Africa, Canada.