Apply now Mgr RA EU Generics Labeling Date Dec 2 2025 Location Bangalore India 560064 Company Teva Pharmaceuticals Job Id 62830 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 current 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 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 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 Reports To In process of validationAlready Working TEVA If you are a current Teva employee please apply using the internal career site available on Employee Central By doing so your application will be treated with priority You will also be able to see opportunities that are open exclusively to Teva employees Use the following link to search and apply Internal Career Site 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 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 Apply now

📌 Mgr Ra Eu Generics Labeling (Karnataka)
🏢 Teva Pharmaceuticals
📍 Karnataka