Novo Nordisk Regulatory Professional II Recruitment Bangalore
Novo Nordisk, a global leader in healthcare with a century-long legacy, is seeking a talented and experienced Regulatory Professional II to join their team in Bangalore. This full-time position requires a candidate with 7-8 years of experience in regulatory affairs and a relevant graduate or postgraduate degree. If you are passionate about regulatory processes and want to make a difference in the life sciences industry, this role is for you.
About the Department
The RA CMC & Device Bangalore department is a crucial part of RA CMC & Device, consisting of over 60 experienced professionals. The team handles key regulatory processes, including Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR), and regulatory file submissions. The department is responsible for driving RA CMC strategies and submission activities related to biotech and rare diseases, diabetes, obesity products, and medical devices. Our mission is to deliver safe and innovative products to patients through strategic business partnering, proactive collaboration with health authorities, and efficient operations.
Job Responsibilities of Novo Nordisk Regulatory Professional II
As a Regulatory Professional II, you will be responsible for making timely submissions to Health Authorities worldwide. Key responsibilities include:
- Establishing and maintaining the CMC part of the core regulatory file.
- Supporting submission planning and developing regulatory strategies.
- Creating and maintaining regulatory submission plans, including document creation and review.
- Handling change requests, deviations, responses to RSI/HA queries, annual reporting, and marketing authorization maintenance globally.
- Supporting NDA, renewals, and post-approval changes.
- Utilizing Veeva Vault for submissions and registrations.
- Managing stakeholder relationships and ensuring effective communication channels.
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Qualifications
To be considered for this role, you should have:
- 7-8 years of experience in regulatory affairs.
- A graduate or postgraduate degree in Life Sciences, Chemistry, Pharmacy, Medicine, or Biotechnology engineering.
- Experience working in both global and affiliate environments.
- A strong understanding of end-to-end regulatory processes and life cycle management.
- Excellent negotiation, project management, and communication skills.
- A proactive approach with the ability to manage multiple priorities.
- High cultural sensitivity and comfort working across different countries and time zones.
How to Apply
If you meet the qualifications and are interested in this exciting opportunity, please apply online through Novo Nordisk's careers page. Click
here to apply.
Application Deadline
Please apply on or before 29th July 2024.
https://pharmastuff.org.in/job/novo-nordisk-hiring-regulatory-professional-ii-bangalore
