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 prospect The Director Regulatory Affairs - Post-Approval US Generics is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U S FDA-regulated generic drug products This role provides regulatory leadership across the organization ensuring compliance with FDA regulations and guidances while driving continuous improvement in lifecycle management processes The Director leads a team of regulatory professionals and serves as a key liaison with the FDA internal stakeholders and external partners How you ll spend your day Define and lead the global regulatory strategy for post-approval lifecycle management of U S FDA-approved ANDAs NDAs ensuring alignment with business goals and regulatory expectations Oversee the preparation review and submission of all CMC post-approval regulatory filings including CMC Supplements CBE-0 CBE-30 and PAS Annual Reports both active and inactive REMS updates general correspondences and controlled correspondences Serve as the primary regulatory authority on post-approval matters providing expert guidance to executive leadership and cross-functional teams Lead regulatory assessments and decision-making for complex changes including site transfers formulation changes alternate APIs etc Establish and maintain strong relationships with FDA project managers Monitor and interpret evolving FDA regulations guidances and enforcement trends proactively adapt strategies and internal processes Develop and implement regulatory policies SOPs and training programs to ensure consistent and compliant practices across the organization Lead mentor and develop a high-performing regulatory team fostering a culture of accountability innovation and continuous learning Represent Regulatory Affairs in global governance forums strategic planning sessions divestment assistance and support of internal initiatives Initiate manage notices of commercial launch and product obsoletion as well as updates to the Orange Book Your experience and qualifications Pharm D or M Pharma in a scientific discipline Minimum 15 years of pharmaceutical industry experience with at least 10 years in U S Regulatory Affairs focused on managing the lifecycle of generic drug products Proven leadership 8 years in a supervisory role in independently managing a large regulatory team as well as a large and diverse post-approval portfolio consisting of various globally manufactured dosage forms and complex supply chains Deep expertise and applied knowledge of FDA regulations 21 CFR 314 70 ICH guidelines and eCTD submission standards Experience with regulatory systems e g Veeva Track Wise and electronic document management systems e g Wisdom Glorya Livelink Knowledgetree Demonstrated success in leading regulatory strategy agency interactions and lifecycle management for ANDAs NDAs Strong business acumen and ability to align regulatory strategies with commercial and operational objectives while maintaining regulatory compliance Demonstrates a basic understanding of pharmaceutical drug development Demonstrated proven track record of FDA interactions as well as negotiation and influencing skills Demonstrates excellent verbal and written communication skills Experience working in a matrixed multinational environment as well as with third parties Experience with regulatory intelligence policy shaping and industry advocacy is a plus Lean Six Sigma certification or other accreditation related to improving business processes is a plus 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 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

📌 Dir Regulatory Affairs (Nagpur)
🏢 Teva Pharmaceuticals
📍 Nagpur