Regulatory Professional II
Category: Regulatory Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, India
Department: RA CMC Biotech and Rare Disease
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 vital part of RA CMC & Device, with over 60 experienced professionals. We handle key regulatory processes, including Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR), regulatory file submissions, product registrations, and life cycle management. We focus on biotech and rare disease products, diabetes, obesity products, and medical devices. Our goal is to deliver safe and innovative products through strategic business partnering, proactive collaboration with health authorities, and efficient operations. We continuously strive for scientific and operational excellence.
Responsibilities
As a Regulatory Professional II, you will:
- Make timely submissions to Health Authorities worldwide.
- Establish and maintain the CMC part of the core regulatory file.
- Manage Life Cycle Management tasks.
- Support submission planning by developing regulatory strategies and creating/reviewing regulatory submission plans.
- Handle submission of regulatory files, change requests, deviations, responses to RSI/HA queries, annual reporting, and maintenance of marketing authorizations globally.
- Support NDA, renewals, and post-approval changes.
- Utilize Veeva Vault for submissions and registrations.
- Manage stakeholder relationships by using appropriate communication channels.
Qualifications
- 7-8 years of experience in Regulatory Affairs.
- Graduate/Postgraduate degree in Life Sciences, Chemistry, Pharmacy, Medicine, or Biotechnology Engineering.
- 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.
