Regulatory Affairs Officer

About Zdravlje

Zdravlje is a trusted B2B pharmaceutical partner with over 70 years of expertise in manufacturing, development, and distribution. We provide end-to-end contract development and manufacturing services for global pharmaceutical companies and offer regional market access for niche pharmaceuticals across Central and Eastern Europe.

Since 2021, Zdravlje has been fully owned by Frontier Biopharma, a UK-based pharmaceutical investor. Driven by quality, innovation, and trust, we are committed to empowering better health outcomes—one product at a time.

Who We’re Looking For:

Are you detail-oriented, organized, and passionate about ensuring medicines reach the market timely and compliantly? We’re looking for a Regulatory Affairs Officer to join our team and help navigate the complex world of pharmaceutical regulations — locally and regionally.

What You’ll Do:

As a key member of our Regulatory Affairs team, you’ll be the bridge between our company, regulatory authorities, and partner companies. You’ll handle everything from preparing documentation to coordinating registrations, renewals, and variations of medicinal products. Your work ensures that patients get safe, approved medicines — on time.

Your Responsibilities Will Include:

• Managing Regulatory Activities
  Plan, organize, and oversee tasks related to product registrations and compliance, aligned with the goals of the commercial team.
• Supporting Product Registrations
  Work on the preparation, submission, and follow-up of new registrations, renewals, and variations in both domestic and international markets.
• Collaborating with Authorities & Partners
  Communicate with ALIMS and partner companies across the region. Coordinate documentation with manufacturers and ensure timely responses to regulatory requirements.
• Document Management
  Maintain, organize, and archive regulatory documentation. Ensure everything is submitted and stored in line with regulations and company procedures. Enter and maintain accurate regulatory information in internal systems and databases
• Promo Material & Import Requests
  Prepare and track approvals for promotional materials submitted to ALIMS. Handle import requests for medicine samples and reference standards.
• Expert Opinion Requests
  Draft and submit applications for expert opinions from ALIMS when needed.
• GDP Compliance & Distribution Oversight       
• Reference: DSo6hn-Sb-CmHyGwJPAIjVpgPoPs0amlp7RB_1B46oo.

As the Responsible Person for wholesale distribution, you’ll also: 

• Oversee product receipt, storage, and delivery
• Ensure medicine quality throughout the supply chain
• Maintain proper records and report any quality issues
• Track and report adverse events related to drugs or medical devices

What You’ll Need:

• A degree in Pharmacy, Medicine, or Dental Medicine
• Previous experience in Regulatory Affairs (at least 2 years)
• Experience in Market Access is a plus
• Experience as a Responsible Person for wholesale distribution is an advantage
• Familiarity with local and international regulatory requirements
• Excellent communication and organizational skills
• Fluency in English
• Confidence working with documentation, databases, and deadlines

Ready to make an impact? Apply now and be a part of our journey!

Only candidates who make it to the shortlist will be contacted.

In the selection process, candidates will not be directly or indirectly discriminated against based on health status, disability, gender, skin color, age, nationality, religion, marital status, sexual or political orientation, membership in various organizations, or any other personal characteristic.