Apply now Mgr Regulatory Affairs - Mature Products Team Date Nov 25 2025 Location Bangalore India 560064 Company Teva Pharmaceuticals Job Id 65165 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 The manager is responsible for the supervision preparation and critical review of high quality regulatory submissions to the regulatory agencies within company timelines and in accordance with regulatory guidelines The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives as needed to his her supervisor The manager will be the product manager for the assigned products and will manage life cycle management activities such as variations renewals responses to HA queries and prepare packages for submission to Health Authorities in the required markets He she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance s The manager will oversee any all regulatory or team databases and trackers and will accurately update them when changes are required The product portfolio will cover mature innovative medicines How you ll spend your day Plans Regulatory Submission Tracker of all Life Cycle Management activities Worldwide Markets for the assigned products Prepare submission strategy as per regulatory requirements in the given markets and works with cross functional teams for final package creation Manages all operational activities as needed in Teva regulatory systems Serves as regulatory representative and works closely with Worldwide markets to ensure timely submission Maintains collaborative partnerships with stakeholders Scope of Life Cycle Management Activities include all variations renewals PSURs DSURs RMPs and responses to queries from Health Authorities EU US Other Markets Provides input to KPI metrics for submissions and approvals Other projects and duties as required assigned Your experience and qualifications Pharm D MS in a scientific discipline or equivalent education and related experience Master s degree in RA QA discipline a plus Prior experience in managing life cycle management regulatory activities a plus Ability to work independently and in a global environment with strong communication skills Minimum 10 years pharmaceutical industry experience required 8 years Regulatory Affairs experience required with experience in EU US Worldwide markets Strong understanding of CMC requirements with hands on experience in US FDA and EU CP regulatory procedures and submissions Demonstrates an understanding of ICH and Regulatory Guidelines for US EU markets Demonstrates the ability to evaluate regulatory documents and determine appropriate action Demonstrates excellent verbal and written communication skills Shares concepts ideas information and suggestions with management peers and others Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts Demonstrates excellent organization skills and the ability to multi-task detail oriented Possesses strong critical and logical thinking 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 chance 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