Regulatory Professional I
1 month ago
Department: Regulatory Affairs CMC & Device
Are 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 “Regulatory Professional”with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.
The Position
As a Regulatory Professional I, 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.
Compile, review and submit Technical Documentation and submission packages, participate in meetings as appropriate. Handle Change Requests (CR), Corrective and Preventive Action (CAPA) cases within area of responsibility. Review of Device documentation, protocols and reports within area of responsibility. Assess the appropriateness of scientific/technical documentation for specific regulatory purposes. Responsible for archiving and retrieving documentation in current archiving system and will re present RA in Notified Body and Health Authority Audits. Active participation in Device core groups (development, production and launch coordination, product maintenance) and GRTs (Global Regulatory Team).Qualification
More than 5 years of experience in related field along with Graduate or Post Graduate Degree Pharma, Biomedical and Engineering graduates preferred. Experience in handling regulatory submissions of medical devices or drug device combination products across the globe. Experience in handling post market changes. Knowledge on MDR and Current Standards is mandatory. Knowledge on Software as Medical Device and exposure to Notified Body audits and interactions is added advantage. Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup.About the department
RA CMC (Chemistry Manufacturing Control) & Device Bangalore is an integral part of RA CMC & Device and comprised of +60 experienced professionals associated with key regulatory processes covering 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 “out of the box”, 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.
Working At Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.
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