Specijalist regulatornih operacija – senior

About the role

The Senior Regulatory Operations Specialist will lead the preparation, submission and lifecycle management of pharmaceutical products across EU and international markets. You will act as the main liaison between internal teams, external partners and regulatory authorities to secure timely approvals.

Key responsibilities

• Assess the quality and completeness of regulatory documentation and coordinate internal and partner activities for timely approvals.
• Prepare, review and submit initial registrations and renewals for products in EU and other markets.
• Manage regulatory procedures throughout the product lifecycle, ensuring prompt response to queries and requests.
• Coordinate regulatory change processes, providing documentation support and expert advice to internal teams.
• Monitor EU and international regulatory guidelines, keep documentation up‑to‑date and suggest process improvements.

Required profile

• Higher education in a biomedical field.
• Minimum 3 years of experience in pharmaceutical drug registration within the EU (experience in EAEU or other markets is a plus).
• Strong knowledge of EU drug regulations; familiarity with other regional requirements is advantageous.
• Excellent time‑management, systematic work approach and persistence.
• Proactive attitude and willingness to acquire new knowledge.
• Active use of English (minimum B2 level) in spoken and written communication.

Required skills

• Proficiency with EU eCTD submission systems.
• Advanced computer literacy, including Office 365.

What we offer

• Opportunity to learn global regulatory requirements across regions such as MENA and ASEAN.
• Direct involvement in shaping regulatory strategies and communicating with EU agencies.
• Work for the largest Croatian pharmaceutical company, present in 60 world markets and recognized as a Top 5 employer in Croatia.
• Young, innovative and entrepreneurial environment that values sustainability and community.
• Comprehensive onboarding, performance management and continuous development programs.