Regulatory Affairs Professional

Regulatory Professional I/ II Company: Novo Nordisk Global Business Services (GBS) Job Level: 6 Are you ready to shape how life-changing medicines reach patients across International Operations? In this role, you'll secure regulatory approvals that open doors for new therapies in markets around the world – and see the direct impact of your work on millions of people living with serious chronic diseases. Your new role As a Regulatory Professional, you will be responsible for securing regulatory approvals for new products (NDA and LCM licences) in due time for specific countries, as well as managing the product's life cycle across approval and post-approval activities. You will act as a trusted regulatory partner to affiliates, distributors and health authorities to ensure timely, compliant delivery in a fast-moving international environment. Your key responsibilities will include: Driving timely submission of applications in line with country-specific Health Authority requirements – reviewing submission content, identifying required documentation and preparing application forms Engaging with distributors and authorities as relevant to secure product approvals and maintain compliance with local HA requirements, including reviewing document lists for tenders and other submissions Ensuring the RA system (Veeva Vault) is updated with product dossier and approval information within agreed timelines Collaborating with affiliate colleagues to develop labelling materials, and reviewing and approving promotional materials and re-packaging specimens in line with local legislation and SOPs Supporting affiliates in monitoring the local regulatory environment and ensuring overall regulatory compliance Your new department The International Operations Regulatory Affairs - Bangalore (IORA Bangalore) is a critical extension of the global IOSO RA (Zurich & Copenhagen) organisation & will together deliver on the function’s aspiration to enable fast growth, portfolio integration & business continuity at scale. The team consist of high calibre regulatory professionals offering core regulatory capabilities enabling Novo Nordisk secure fast, high quality product approvals across International Operations. Your skills & qualifications We're looking for a highly self-motivated, proactive and organised regulatory professional with strong stakeholder management and communication skills. To succeed in this role, you'll bring: Post-Graduation or comparable degree in science. Above 5 years of experience in pharmaceutical industry in Regulatory Affairs. 3+ years working with key stakeholders and decision makers outside India in a cross-functional, international environment. Experience of working in an Affiliate environment & shared service model preferred Good understanding of E2E regulatory processes. Hands on experience on handling conversations with Health authority preferred. Hands on experience in compilation of registration/re-registration dossier in national / eCTD / NeeS / ACTD & standard format. Good understanding of Veeva Vault RA systems Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones Basic project management & excellent written/spoken communication skill Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations. What we offer There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. Deadline 20 July 2026. Applications are reviewed on an ongoing basis, so please apply as soon as possible. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. Experience Level Mid Level