Category: Reg Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, IN
Global Regulatory Affairs 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 “Senior Regulatory Professional” with us. “Apply now” – At Novo Nordisk, we assure you will experience the best.
About the Department
RA CMC & Device Bangalore in Global Business Services (GBS) Bangalore is a part of Bangalore Global Development hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product and device approvals. The team delivers full strategic and operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We provide regulatory expertise in terms of CMC & Medical Devices, Combination Products and work very closely with our colleagues in Denmark (DK) as well as colleagues in our affiliates all over the world. That makes Regulatory Affairs truly interesting and challenging to work.
As 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.
- Compile, review and submit Technical Documentation and submission packages, participate in meetings as appropriate.
- Handle Change Requests (CR), 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 represent 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).
- More than 8 years of experience in related field along with 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.
- 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.
Working At Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales- we’re all working to move the needle on patient care.
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.
Apply on or before: 09th Feb, 2024
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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