Job Description

Job description Bangalore, India Job category Reg Affairs Safety Pharmacovigilance Department: IOSO Regulatory Affairs Bangalore Are you a visionary leader passionate about making an impactDo you strive to build excellence within processes in the most efficient wayDo you have an innovative mindset to drive change in a future-ready environmentAre you ready to lead and inspire a high-performing teamIf so, raise your hand because an exciting leadership opportunity awaits you as Manager International Operations Regulatory Affairs - OCE with us. Apply Now At Novo Nordisk, we assure you will experience the best. The Position Novo Nordisk is seeking a dynamic and experienced Regulatory Manager to lead our IORA OCE team, playing a pivotal role in driving business performance and ensuring regulatory excellence. This leadership position involves overseeing team performance and ensuring the quality of regulatory outputs across key markets. The OCE team delivers comprehensive regulatory support for NDA and LCM applications, post-approval changes, and QA, including interactions with local Health Authorities. Key Responsibilities: Strategic Leadership: Provide leadership and strategic direction to the team. Formulate and execute regulatory strategies that align with overarching IO regulatory objectives while fostering the growth and expansion of IORA OCEs. People Resource Management: Inspire, mentor, and cultivate a high-performing team. Lead efforts in recruitment, performance management, and fostering a culture of engagement and development. Business Operational Performance: Ensure the seamless execution of regulatory processes. Optimize workflows to enhance efficiency and continuously drive improvements in regulatory operations. Quality, Compliance EHS: Uphold compliance with the Quality Management System (QMS) and adhere to all internal and external regulatory standards. Foster a safe and healthy working environment for all employees. Stakeholder Collaboration: Develop and maintain strong relationships with global, regional, and affiliate regulatory teams. Ensure effective communication and cross-functional collaboration to achieve regulatory success. Innovation Process Optimization: Lead innovation by identifying opportunities for efficiency and implementing best practices. Identify white spaces for centralization, strive to eliminate process bottlenecks and accelerate submission and approval timelines. Qualifications Graduate/Postgraduate in Science, Pharmacy, Medicine, or a relevant field. 8+ years in Regulatory Affairs or relevant functions and minimum 3 years of leadership experience managing teams in a regulatory or compliance-driven environment. Knowledge of Regulatory Global processes, International commercial Regulatory frameworks intelligence, including country specific NDAs/LCMs rollouts. Proficiency in Regulatory Systems including Veeva Vault RIM and Compliance Standards. Strong understanding of the Drug Development Process RD Value Chain. Expertise in Project Management for regulatory initiatives. Business Commercial Acumen to align regulatory strategy with commercial goals. About the department The International Operations Strategic Operations Regulatory Affairs - Bangalore (IOSO RA 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 project management capabilities enabling NN secure fast, high quality product approvals across International Operations. Working at Novo Nordisk Contact If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool. Deadline Apply on or before: 21st March 2025. Disclaimer Related jobs