Novo Nordisk Pharma Regulatory Affairs Professional Job – Apply Online
Regulatory Professional I
Category: Reg Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, IN
About the Company
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 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.Responsibilities:
- 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).
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.
Contact
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. Internal candidates are kindly requested to inform their line Manager before applying. We don’t take applications via direct mail.
Deadline
Apply on or before: 1st January 2024
Keywords: Regulatory Professional, Regulatory Affairs, Safety Pharmacovigilance, Bangalore, Karnataka, Global Regulatory Affairs, Medical Devices, Combination Products, Technical Documentation, Notified Body, Health Authority Audits, MDR, Current Standards, Software as Medical Device. Novo Nordisk Pharma Regulatory Affairs Professional Job – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
