Mgr Regulatory Affairs Date: Sep 5, 2025 Location: Bangalore, India, 560064 Company: Teva Pharmaceuticals Job Id: 63860 **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** + Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company. + Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases. + Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction. . **How you’ll spend your day** Regulatory Submissions + Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region. + Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity. + Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc) Regulatory Intelligence/Expertise/Guidance/Education + Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities + Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams.. + Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system. + Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements. + Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them. + Work closely with market RA in APAC region to complete all assigned activities **Your experience and qualifications** + B. Pharm / M. Pharm (preferred) with 10+ years of experience + Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices. + Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc) **Already 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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte\_company=1080030P) 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. EOE including disability/veteran