Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location: Zagreb, Croatia

Join AstraZeneca

At AstraZeneca, we are driven by a passion for science and a commitment to transforming the lives of patients worldwide. Our work is focused on delivering life-changing medicines through innovation, collaboration, and excellence. As a global, science-led biopharmaceutical company, we empower our employees to make a meaningful impact while developing their careers in a dynamic and supportive environment.

We are seeking a Regulatory Affairs Specialist to join our Balkans Cluster Regulatory Affairs team. Reporting to the Regulatory Affairs Lead, Balkans EU Countries, you will play a critical role in ensuring regulatory compliance, supporting product lifecycle management activities, and delivering successful regulatory submissions that enable patients to gain timely access to AstraZeneca medicines.

What You'll Do

As a Regulatory Affairs Specialist, you will be responsible for supporting the regulatory management of AstraZeneca's product portfolio, ensuring compliance with local and European regulatory requirements while contributing to key business objectives.

Key Responsibilities

Regulatory Affairs

• Prepare and manage regulatory submissions for National, MRP, and DCP procedures.

• Coordinate and execute Linguistic Reviews for centrally approved products in accordance with AstraZeneca procedures and regulatory requirements.

• Support lifecycle management activities, ensuring timely and high-quality submissions.

• Contribute local documentation for ERV regulatory submissions using AstraZeneca regulatory systems.

• Communicate regulatory outcomes, commitments, and approval status updates within established timelines.

• Serve as an MC Regulatory Approver and Reviewer within the NG Gazelle labelling system and act as Regulatory Initiator when required.

• Maintain regulatory databases, ERV records, and local SharePoint documentation with the latest approved product information.

• Support continuous improvement initiatives and contribute positively to the development of the Regulatory Affairs function.

Labelling & Packaging

• Coordinate the creation and maintenance of Croatian-language market-specific and shared-pack labelling through AstraZeneca's global systems.

• Ensure compliance with local legislation and AstraZeneca global labelling procedures.

• Collaborate closely with Logistics teams on regulatory labelling changes and implementation plans.

Systems & Compliance

• Act as the local administrator for the EUCAN Launch Tracker, managing user access and supporting training activities.

• Support Good Regulatory Practice (GRP) activities, including Enterprise Quality Vault updates and maintenance of local procedural documentation.

Essential Requirements

• Degree in Life Sciences, Pharmacy, or another relevant scientific discipline, or statutory qualifications required within the local market.

• Experience working within Regulatory Affairs in the pharmaceutical industry.

• Knowledge of EU regulatory requirements and pharmacovigilance regulations.

• Strong verbal and written communication skills.

• Excellent command of English.

• Digital and AI literacy.

• Experience using regulatory systems and processes.

• Strong attention to detail with a focus on quality, accuracy, and compliance.

Desirable Qualifications

• Knowledge of drug development, product lifecycle management, and regulatory submission requirements.

• Understanding of EU marketing authorisation procedures and post-approval regulatory activities.

• Experience working with labelling systems and regulatory databases.

What We're Looking For

We are looking for a proactive and detail-oriented professional who demonstrates:

• Strong results orientation and ownership

• Excellent collaboration and teamwork skills

• Analytical thinking and effective problem-solving abilities

• High levels of accuracy and thoroughness

• Persistence and resilience when managing complex regulatory processes

• A commitment to continuous learning and improvement

Why AstraZeneca?

At AstraZeneca, you'll be empowered to make a real difference. You'll work alongside talented colleagues across Medical Affairs, Market Access, Logistics, Global Regulatory Affairs, and cross-functional international teams while helping bring innovative medicines to patients across the region.

Join us and be part of a company where science, innovation, and patient focus drive everything we do.

Ready to make an impact? Apply today and help shape the future of healthcare with AstraZeneca.