Regulatory Professional I/ II

Job description

Are you ready to shape how life-changing medicines reach patients across International Operations In this role, youll 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 products 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** Were looking for a highly self-motivated, proactive and organised regulatory professional with strong stakeholder management and communication skills. To succeed in this role, youll 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 Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.