- Full Time
Website Novo Nordisk
About Novo Nordisk
Novo Nordisk is indeed a renowned global healthcare company with a remarkable 89-year history of innovation and leadership in the field of diabetes care. The company has consistently been at the forefront of diabetes treatment and research, making significant contributions to improving the lives of people living with diabetes.
In addition to their pioneering work in diabetes care, Novo Nordisk has established leading positions in other critical areas of healthcare. This includes Haemophilia care, where they have developed and provided advanced therapies to manage this complex bleeding disorder. They are dedicated to improving the quality of life for individuals with Haemophilia.
Novo Nordisk is also a leader in the field of growth hormone therapy, offering innovative solutions for individuals with growth-related disorders. Their commitment to research and development has allowed them to make significant strides in this area.
Furthermore, the company plays a vital role in hormone replacement therapy, which is essential for individuals who require replacement hormones due to various medical conditions. Novo Nordisk’s expertise and products in this field have helped countless patients achieve a better quality of life.
Overall, Novo Nordisk’s longstanding commitment to innovation and its leadership in multiple healthcare sectors, particularly in diabetes care, Haemophilia care, growth hormone therapy, and hormone replacement therapy, have made it a globally respected and trusted healthcare company. Their work continues to have a positive impact on the health and well-being of millions of people worldwide.
About the Regulatory Affairs Department
In the world of healthcare, Regulatory Affairs plays a crucial role in ensuring that Novo Nordisk’s Medicines and Devices meet compliance standards and prioritize patient well-being. This department acts as a vital liaison between relevant authorities and Novo Nordisk stakeholders, actively participating throughout the product development phases, New Drug Application (NDA) processes, and the maintenance of Life Cycle Management (LCM) activities. The Regulatory Affairs team comprises professionals with diverse academic and professional backgrounds, offering invaluable insights and expertise. This diversity ensures swift market access and maintains exceptionally high professional standards. Join Regulatory Affairs for a truly multi-disciplinary environment with abundant opportunities for rapid professional growth and a promising career.
As a Regulatory Professional, your primary responsibility will be to ensure the timely submission of critical documents to Health Authorities worldwide. This role entails establishing and maintaining the Chemistry, Manufacturing, and Controls (CMC) section of the core regulatory file. Additional responsibilities include active involvement in Life Cycle Management.
- Contribute to submission planning by applying strategic intelligence.
- Develop and maintain the Regulatory Submission Plan, including the creation and review of essential documents.
- Provide support for the submission of Regulatory files, handling Change Requests and Deviations, responding to Regulatory Safety Information (RSI) and Health Authority (HA) queries on a global scale, managing annual reporting, and maintaining marketing authorizations worldwide.
- Play a key role in New Drug Application (NDA) submissions, renewals, and post-approval changes.
- Exhibit proficiency in using Veeva Vault for submission and registrations.
- Take a central role in stakeholder management, utilizing appropriate communication channels to strengthen relationships with key stakeholders.
- 7-8 years of Regulatory Affairs experience, with a Graduate or Postgraduate degree in Life Science, Chemistry, Pharmacy, or Medicine.
- Preference given to candidates with experience in both Global and Affiliate environments.
- Demonstrated understanding of end-to-end Regulatory Processes and Life Cycle Management.
- Possess a bold and strong personality with proven negotiation skills.
- Able to articulate facts confidently and persuasively.
- Highly proactive, capable of taking initiative, and managing multiple priorities.
- Self-managed, driven, and able to engage with colleagues and peers to deliver excellent performance and results.
- Exhibit high cultural sensitivity and comfort working with various countries and cultures across multiple time zones.
- Strong written and spoken communication skills.
- Experience Required: 5+ years
- Qualifications: Graduate or Postgraduate degree in Life Science, Chemistry, Pharmacy, or Medicine
- Location: Bangalore
- Industry Type: Pharma/ Healthcare/ Clinical Research
- Functional Area: Regulatory Affairs, CMC (Chemistry, Manufacturing, and Controls) – Diabetes & Obesity
- Application Deadline: November 20, 2023
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To apply for this job please visit www.novonordisk.co.in.