Teva Mgr RA EU Generics Labeling 

India, Karnataka, Bengaluru 

45603555

• 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.

CONTD...

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: 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.