Compliance

• Ensure all Product Licenses in Kosovo remain fully up-to-date and compliant
• Manage regulatory documentation, submissions, approvals, systems, and databases
• Communicate application progress and changes to registered details with local and global stakeholders
• Interact and negotiate with local Health Authorities and internal stakeholders
• Participate in shaping the policy environment
• Develop working relationships with regulators in Kosovo, Roche International Regulatory, and key customers
• Monitor local and international regulatory legislation and regulatory-environment changes
• Communicate changes in local Kosovo regulations to Roche Global and local stakeholders
• Gather and disseminate regulatory intelligence within the Affiliate
• Align regulatory filings with commercial and supply needs to support business continuity
• Develop risk-based regulatory strategies and work plans for assigned products or business areas
• Collaborate with affiliate, regional, and global functions
• Support regulatory audit and inspection readiness, including leading or participating in audits
• Ensure Affiliate activities comply with Roche global standards and local regulations
• Prepare and maintain product information and packaging components in line with reference labeling
• Collaborate with global supply, artworks, Pharma technical, labeling, and affiliate stakeholders to ensure efficient workflows

Explore Regulatory Affairs Specialist at Roche. Review requirements and application details.