Novo Nordisk Hiring for Regulatory Professional II @Bangalore
About Company
Novo Nordisk is a global healthcare leader with a century-long legacy of combating serious chronic diseases. With over 63,000 employees, we aim to impact more than 40 million lives daily. Join us and be part of a diverse and inclusive team.
Position Name: Regulatory Professional II
Organization: Novo Nordisk
Location: Bangalore, Karnataka, India
Category: Regulatory Affairs & Safety Pharmacovigilance
Department: RA CMC Biotech and Rare Disease
Salary: ₹2.00 – ₹5.4 lac (Approx)
Qualification:
- Graduate/Postgraduate degree in Life Sciences, Chemistry, Pharmacy, Medicine, or Biotechnology Engineering.
Experience:
- 7-8 years
About the Role
Are you passionate about your work? Do you strive for excellence in processes and efficiency? Do you have an innovative mindset to drive change in a future-ready environment? If yes, we have an exciting opportunity for you as a Regulatory Professional II at Novo Nordisk. Apply now to join us and experience the best.
About the Department
RA CMC & Device Bangalore is a key part of RA CMC & Device, with over 60 professionals. We handle critical regulatory processes, including Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR), regulatory file submissions, product registrations, and life cycle management. Our focus includes biotech and rare disease products, diabetes, obesity products, and medical devices. We aim to deliver safe and innovative products through strategic business partnering, collaboration with health authorities, and efficient operations.
Responsibilities
| Responsibilities | Details |
|---|---|
| Submissions | Make timely submissions to Health Authorities worldwide. |
| CMC Management | Establish and maintain the CMC part of the core regulatory file. |
| Life Cycle Management | Manage Life Cycle Management tasks. |
| Submission Planning | Develop regulatory strategies and create/review submission plans. |
| Regulatory Files | Handle submission of regulatory files, change requests, deviations, responses to RSI/HA queries, annual reporting, and maintenance of marketing authorizations globally. |
| NDA & Renewals | Support NDA, renewals, and post-approval changes. |
| Veeva Vault | Utilize Veeva Vault for submissions and registrations. |
| Stakeholder Management | Manage stakeholder relationships using appropriate communication channels. |
Qualifications
- 7-8 years of experience in Regulatory Affairs.
- Preferred experience in both Global and Affiliate environments.
- Strong understanding of end-to-end regulatory processes and life cycle management.
- Proven negotiation and project management skills.
- Proactive, with the ability to manage multiple priorities.
- High cultural sensitivity and comfortable working across different time zones.
- Excellent written and spoken communication skills.
How to Apply
If you meet the above requirements and are interested in this role, please apply using our online application tool.
Application Deadline: 29th July 2024
We are committed to an inclusive recruitment process and equal opportunity for all applicants. We aim to be the best company for the world by fostering a diverse and inclusive culture. Together, we’re life-changing.
