Regulatory Specialist
1 week ago
Department: RA CMC & Device
Are you passionate about your work? 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 "RA Specialist" with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.
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.
The position
As a RA Specialist, the ideal candidate will be responsible to design RA Strategy from late stage development and throughout Life cycle of the device project, 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. RA Specialist will be an SME for the defined area of responsibility. Mentor and provide technical sparring to project team on device regulatory pathways
Key tasks and responsibilities will be:
Regulatory Strategy Development: Develop and implement regulatory strategies for Drug-Device Combination products in alignment with current legislation, ensuring compliance with regulatory requirements and standards. Documentation Management: Compile, review, and submit Technical Documentation and submission packages, while ensuring the appropriateness of scientific/technical documentation for specific regulatory purposes. Stakeholder Support: Provide effective support and advice to stakeholders to minimize time to market, facilitating timely product approvals and launches. Engagement with Health Authorities: Maintain dialogue, negotiate, and represent Novo Nordisk in interactions with relevant health authorities and notified bodies, ensuring compliance and fostering positive relationships. Project Management and Coordination: Plan, coordinate, and project manage regulatory activities, including handling Change Requests, corrective and preventive actions (CAPA) cases, and representing Regulatory Affairs in audits and core groups for device development, production, and launch coordination.Qualifications
A Graduate or Post Graduate Degree in Pharma, Biomedical and Engineering graduates preferred. Experience in handling regulatory submissions of medical devices or drug device combination products across the globe. Depending on the qualification, ideally more than 10 years experience in handling RA activities of Combination products, connected Medical Devices either from the pharmaceutical industry, medical device industry, notified bodies or from a medical agency Experience in handling regulatory submissions and post market changes of medical devices, Drug-Device Combination products globally. Knowledge on MDR and Current Standards is mandatory. A scientific and technical mindset with familiarity on matrix organisation set-up. Experience in project management and experienced with process management in highly regulated environment. Ability to communicate on complex topics scientifically and professionally to different stakeholders across the organisation. Strong communication skills and fluency in written and spoken English. Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup.-
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