Regulatory Affairs Specialist

About This Role

This role ensures that all product licenses in Kosovo are always fully up-to-date and compliant, managing regulatory documentation and submissions. It involves interacting and negotiating with local health authorities and internal stakeholders to achieve successful regulatory outcomes and actively shaping the policy environment. The specialist will also develop and manage effective working relationships with regulators and other key customers.

Responsibilities

• Ensure that all Product Licenses in Kosovo are always fully up-to-date and compliant
• Be responsible for ensuring that all regulatory documentation is effectively managed and that all regulatory submissions and approvals are accurately documented within relevant systems and databases
• Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate, with minimum delay
• Interact and negotiate with local HAs and internal stakeholders to build and cultivate trusted partnerships and achieve successful regulatory outcomes
• Take active participation in shaping the policy environment
• Develop and manage effective working relationship with the regulators in Kosovo, Roche International Regulatory and other key customers
• Maintain a level of knowledge of local and international regulatory legislation and awareness of changes within the regulatory environment
• Ensure the timely communication on changes in local (Kosovo) regulations to Roche Global and to the local stakeholders in accordance with Roche requirements
• Gather and disseminate regulatory intelligence within the Affiliate, as assigned
• Ensure regulatory filings are aligned with commercial and supply needs to assure business continuity and provide Regulatory Affairs input into relevant cross-functional Affiliate business strategies
• Develop innovative, risk-based regulatory strategies and work plans for assigned products or business areas within the Affiliate to accelerate access of medicines to patients
• Build strong relationships and ensure good collaboration and communication between LTO and other affiliate, regional and global functions
• Support regulatory audit/inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits
• Ensure assigned Affiliate activities comply with Roche global standards and local regulations
• Prepare and maintain product information for regional make-up in line with the reference label, and partner with global labelling, artworks, supply chain and affiliates to ensure implementation of packaging components within agreed company timelines
• Prepare packaging components (primary, secondary and product leaflet) in alignment with reference label through the lifecycle maintenance