Regulatory Affairs Specialist

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.
• Builds strong relationships and ensures 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.
• Prepares and maintains product information for regional make-up in line with the reference label, and partners with global labelling, artworks, supply chain and affiliates to ensure implementation of packaging components within agreed company timelines.
• Prepares packaging components (primary, secondary and product leaflet) in alignment with reference label through the lifecycle maintenance
• Works in close collaboration with global stakeholders (e.g. supply, artworks, Pharma technical) and affiliates to ensure efficient workflows with functions involved in the labelling processes.

II. Competencies:

• High degree of proficiency in Albanian and English language.
• Strong verbal and written communication skills.
• Analytical and problem solving skills.
• Ability to work as part of a team.
• Excellent listening and decision-making skills.
• Well-organized, detail oriented professional and ability to prioritize and make decisions.
• Highly self-motivated; able to lead initiatives with authority.

III. Experience, Skills, Knowledge:

• Location: Based in Kosovo or North Macedonia.
• University education - pharmacist
• Experience in the pharmaceutical industry and in a regulatory environment.
• Excellent understanding of the pharmaceutical industry, drug development environment.
• Extensive knowledge of relevant regulations and ability to evaluate the impact of those regulations within the external and internal environment.
• Commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines

This role is a 12-months temporary cover for maternity leave.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.