Roles & Responsibilities
• Secure regulatory approvals for new products (NDA, LCM) within defined timelines
• Manage product lifecycle activities including submissions, variations, and renewals
• Prepare and review regulatory submission dossiers and application forms as per country-specific Health Authority requirements
• Coordinate with distributors, affiliates, and health authorities to ensure regulatory compliance
• Handle regulatory documentation for tenders and special submissions
• Update and maintain regulatory information in Veeva Vault within agreed timelines
• Support labeling development, review promotional materials, and ensure compliance with local regulations
• Monitor regulatory environment changes and support post-approval regulatory activities
Qualification
• Post-Graduation or equivalent degree in Science
Experience
• Minimum 5+ years of experience in Regulatory Affairs within the pharmaceutical industry
• At least 3 years of experience working in cross-functional, international or affiliate environments
• Experience handling interactions with Health Authorities preferred
Skills
• Regulatory submissions and lifecycle management
• Health Authority interactions
• Regulatory documentation and compliance
• Veeva Vault (Regulatory systems)
• Project management and prioritization
• Cross-functional collaboration and stakeholder management
About the Organisation
Novo Nordisk is a global healthcare company with over a century of experience in developing innovative treatments for chronic diseases. Driven by a strong patient-centric mission, the organization focuses on delivering high-quality, compliant, and sustainable healthcare solutions across international markets.
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