Pharma Job at Novo Nordisk – Apply Online Now!
About the company:
Novo Nordisk is a leading global pharmaceutical company that specializes in diabetes and obesity care. With a commitment to excellence and innovation, we strive to make a positive impact in the lives of patients worldwide. Join us and be part of a future-ready environment where your skills and passion can thrive. Apply now!
Job Description
Location: Bangalore, India
Job Category: Regulatory
Department: RA CMC Diabetes & Obesity
Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “CMC Regulatory Professional” with us. “Apply now” – At Novo Nordisk, we assure you will experience the best.
About the Department
Regulatory Affairs plays an important role in ensuring all Novo Nordisk Medicines and Devices are developed with compliance and keeping patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs will be involved throughout phases of product development, NDA, and maintenance of
LCM activities. Our people in Regulatory Affairs come from diverse academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure a minimum time to reach the markets. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities.The Position
As a Regulatory Professional, you will be responsible for making timely submissions to Health Authorities worldwide. You will be expected to establish and maintain the CMC part of the core regulatory file. Further responsibilities include Life Cycle Management.
Key Responsibilities:
- Support submission planning: Apply intelligence and develop Regulatory strategy.
- Create and maintain Regulatory Submission Plan including creation/review documents.
- Support submission of Regulatory files, Handling Change Requests & Deviations, response to RSI/HA query worldwide, Annual Reporting, and maintenance of marketing authorization globally.
- Support NDA, Renewals & Post Approval Changes.
- Hands-on experience with Veeva Vault (Submission & Registrations).
The candidate will play a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders.
Qualifications
- 7-8 years of experience within Regulatory affairs with a Graduate/Postgraduate degree in Life-Science/Chemistry/Pharmacy/Medicine.
- Experience of working both in the Global & Affiliate environment will be preferred.
- Good understanding of end-to-end Regulatory Processes and Life Cycle Management.
- Bold and strong personality with proven negotiation skills.
- Should be able to convince and put forward the facts confidently.
- Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive, and ability to engage with colleagues and peers towards delivering excellent performance and results.
- High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.
- Excellent written/spoken communication skills.
Click here to apply now.
Keywords: Pharma Job, Novo Nordisk, Apply Online, Regulatory Professional, Bangalore, India, RA CMC Diabetes & Obesity.
