Teva Vodeći inženjer održavanja automatiziranih sustava m/ž 

Croatia, Zagreb 

908324157

• Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.

1. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Strategic planning and implementation of changes affecting multiple product information documents.
• Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update).
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.

1. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
2. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV triggered and non-PV triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
3. Scientific Work & Authority Communication
• Participate in project teams to fix the regulatory strategy and prepare expert statements.
• Respond to authority deficiency letters in collaboration with other departments.
4. Mockups
• Coordinate creation and approval of packaging mockups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
5. Training
• Assist with training new team members

• Experience: 10+ years of total experience and minimum 6 to 7 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a PhD.
• Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.