Regulatory Specialist

Location

Bangalore | India

Job description

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 & 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 “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 to:

• Develop and implement regulatory strategies for Drug-Device Combination products aligned with current legislation.
• Compile, review and submit Technical Documentation and submission packages, participate in meetings as appropriate.
• Ensure minimum time to market through effectively supporting and advising the stakeholders.
• Maintain dialogue and negotiate with relevant health authorities and notified body.
• Plan, coordinate, project manage and submit regulatory files for product approval.

• Handle Change Requests (CR), CAPA cases within area of responsibility.
• Review of technical 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.
• 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).

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.

Working at Novo Nordisk

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

Contact

If you believe you are a match for the above requirements and are highly motivated to take up the role, please apply here with our online application tool.

Deadline

Apply on or before: 11th March 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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Salary