Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Regulatory Specialist
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.
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).
Candidate Profile
• 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.
Additional Information
Qualification : Graduate or Post Graduate Degree in Pharma
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Reg Affairs & Safety Pharmacovigilance
End Date : 30th March 2024
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