Regulatory Affairs Associate III
Bangalore, India, 560064
Who we are
The opportunity
- 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.
How you’ll spend your day
- Labeling
- Responsible for creating and updating compliant English product information for EU procedures.
- 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.
- Monitoring
- Monthly monitoring and communicating safety updates from EU authority websites.
- Track reference product updates and legal/guidance changes affecting product information.
- 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).
- Scientific Work & Authority Communication
- Respond to authority deficiency letters in collaboration with other departments.
- Mockups
- Coordinate creation and approval of packaging mockups, Braille, and specimens.
- Address authority queries and ensure compliance with EU regulations.
Your experience and qualifications
- Experience: 5 to 6 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)
- Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European Pharmaceutical Law and Regulatory Affairs.
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