Regulatory Affairs Specialist (Temporary Cover)

About the role

Roche is looking for a Regulatory Affairs Specialist to cover a 12-month maternity leave assignment. The role is based in Kosovo or North Macedonia, with the primary posting location being Prishtina. It covers regulatory compliance, submissions and documentation for products in Kosovo.

Key responsibilities

• Keep all product licenses in Kosovo fully up to date and compliant
• Manage regulatory documentation and ensure submissions and approvals are recorded in the right systems
• Communicate progress of applications and changes to registered details to local and global stakeholders
• Build trusted partnerships with local health authorities and internal stakeholders
• Stay up to date on local and international regulations and share changes with Roche Global and local stakeholders
• Gather and share regulatory intelligence within the affiliate
• Align regulatory filings with commercial and supply needs and give input to cross-functional business strategies
• Develop risk-based regulatory strategies and work plans for assigned products or business areas
• Support audit and inspection readiness, including taking part in internal and external regulatory audits
• Prepare and maintain product information and packaging components (primary, secondary and leaflets) in line with the reference label, working with global stakeholders and affiliates

Required profile

• University education as a pharmacist
• Experience in the pharmaceutical industry and in a regulatory environment
• Excellent understanding of the pharmaceutical industry and drug development environment
• Knowledge of relevant regulations and their impact internally and externally

Required skills

• High proficiency in Albanian and English
• Analytical and problem-solving skills, attention to detail and ability to prioritize
• Team player with strong communication and decision-making skills