Department: Regulatory Affairs CMC & DeviceAre you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as \xe2\x80\x9cSenior Regulatory Professional\xe2\x80\x9d with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.About the departmentRA CMC & Device Bangalore is an integral part of RA CMC & Device and comprised of +60 experienced professionals associated with key regulatory processes covering Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR) and submission of regulatory files, product registrations and life cycle management of our products. We are responsible for driving the RA CMC strategies and submission activities related to various biotech and rare disease, Diabetes & obesity products and medical devices.We strive to be the best in the industry, delivering safe and innovative products to the patients by strategic business partnering, proactive collaboration with health authorities and efficient operations.Our organization is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking \xe2\x80\x9cout of the box\xe2\x80\x9d, setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients we serve. we continuously strive for scientific and operational excellence.Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people.The PositionAs a Senior Regulatory Professional, the ideal candidate will be responsible to plan, prepare and submit high quality files to the authorities achieving fast approvals. Act as an ambassador for assigned medical devices/device part of combination products. This role involves planning, coordinating and executing the regulatory tasks as required for existing device products in accordance with the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with manager and colleagues. Senior Regulatory Professional acts an SME for the defined area of responsibility. Mentor and provide technical sparring to project team on device regulatory pathways.
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