Apply now Regulatory Affairs Associate III Date Nov 21 2025 Location Navi Mumbai India 400706 Company Teva Pharmaceuticals Job Id 65039 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 Responsible for driving all the activities independently pertaining to Regulatory Affairs of assigned project for Solid Oral Dosage forms How you ll spend your day Independently compile high-quality CMC m2 m3 dossier and review the compilation of peers for new registration query responses to review letters from agency and post approval supplements on need basis for EU in CTD format as per the submission timelines Additional support leveraging dossiers for International Market regions Assist submissions team with CMC related m1 administrative documentation Provide strategic input and regulatory intelligence to allotted R D projects including cross-functional initiatives Effective supervision and coaching of peers junior team members Support due diligence process pre-filing and implement action plan to address deficiencies Assess submission documentation in consideration and compliance with the regulatory requirements and to provide inputs to cross functional teams Coordinate on need basis with external parties and cross functional teams to obtain essential scientific data and documents required for regulatory submissions Escalate key issues to management risk of delays to submissions risk to approvability complex supporting data requirements To deputize for Manager during his her absence Your experience and qualifications Qualification Graduation Post graduation in Science Pharma discipline Desired Experience Minimum 6 Yrs for post-graduates 8 Yrs for graduates in core pre-approval regulatory activity in EU and allied markets for Solid Oral Dosage forms Preference for additional experience in formulation analytical development Regulatory knowledge throughout new development product lifecycle with substantial experience with various products and on different Markets Teva s Equal Employment Prospect 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