Mgr RA EU Generics Labeling
Date:
Aug 20, 2025
Location:
Bangalore, India, 560064
Company:
Teva Pharmaceuticals
Job Id:
62835
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
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.
- 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...
- 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
- Participate in project teams to fix the regulatory strategy and prepare expert statements.
- 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.
- Training
- Assist with training new team members
Your experience and qualifications
- 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.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
