At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

I. Summary of Main Responsibilities:

• Ensure that all Product Licenses in Kosovo are always fully up-to-date and compliant
• 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
• As assigned, gather and disseminate regulatory intelligence within the Affiliate
• 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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

I. Summary of Main Responsibilities:

• Ensure that all Product Licenses in Kosovo are always fully up-to-date and compliant
• 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
• As assigned, gather and disseminate regulatory intelligence within the Affiliate
• 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