Regulatory Affairs Specialist

Roche

. Ensure all Product Licenses in Kosovo remain fully up-to-date and compliant .

Posted 10/22/2026full-timePrishtina • KosovoMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and documentation management within the pharmaceutical industry, with strong communication and analytical skills to navigate local and global regulatory environments effectively.

Highest-signal resume keywords

Regulatory Compliance ManagementPharmaceutical Industry ExperienceBilingual Proficiency in Albanian and EnglishRegulatory Documentation and SubmissionsAnalytical and Problem Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRisk-Based Regulatory StrategiesRegulatory Intelligence GatheringRegulatory Audit ParticipationProduct License ManagementRegulatory Legislation MonitoringDocumentation ManagementDrug Development UnderstandingRegulatory Environment EvaluationPackaging Component Preparation

Soft Skills

Strong Verbal and Written CommunicationExcellent Listening SkillsDecision-Making SkillsTeam CollaborationDetail Oriented

Certifications & Qualifications

University Education – Pharmacist

Industry Keywords

Regulatory EnvironmentHealth Authorities InteractionStakeholder CommunicationPolicy Environment ShapingBusiness Continuity SupportAudit and Inspection ReadinessLocal Regulations CompliancePharmaceutical StandardsRoche Global StandardsKosovo Regulatory Framework

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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 with ability to prioritize and make decisions
Highly self-motivated; able to lead initiatives with authority
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 and drug development environment
Extensive knowledge of relevant regulations and ability to evaluate their impact within the external and internal environment
Commitment to deliver high quality output under regulatory deadlines

Benefits

Comp & perks

12-month temporary cover for maternity leave
Equal Opportunity Employer