Regulatory Affairs Specialist

Welcome to Novo Nordisk, a global healthcare company dedicated to improving the lives of people living with chronic diseases. We are currently seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist. In this role, you will play a crucial role in ensuring compliance with regulatory requirements and contributing to the success of our products on a global scale. We are looking for someone with a passion for the pharmaceutical industry and a strong understanding of regulatory processes. If you are a proactive and driven individual who thrives in a fast-paced environment, we would love to hear from you. Join us in our mission to make a difference in the lives of patients around the world.

1. Ensure compliance with all applicable laws, regulations, and guidelines related to the development and commercialization of pharmaceutical products.
2. Provide support and guidance to cross-functional teams on regulatory requirements and processes.
3. Prepare and submit regulatory submissions, including but not limited to marketing applications, clinical trial applications, and variations.
4. Monitor and track regulatory submissions and approvals to ensure timely execution.
5. Review and assess scientific data and literature to support regulatory submissions.
6. Communicate with regulatory agencies to address any questions or requests for additional information.
7. Develop and maintain relationships with key stakeholders, including internal teams and regulatory authorities.
8. Stay updated on changes to regulatory requirements and guidelines and provide recommendations for compliance.
9. Participate in internal and external audits and inspections related to regulatory affairs.
10. Collaborate with the global regulatory team to ensure consistency and alignment in regulatory strategies.
11. Provide support for product launches and post-market activities.
12. Contribute to the development and implementation of SOPs and other regulatory processes.
13. Manage timelines and prioritize tasks to meet regulatory deadlines.
14. Act as a subject matter expert on regulatory requirements and processes for the organization.
15. Uphold Novo Nordisk's values and commitment to improving the lives of patients with chronic diseases.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Copenhagen, Denmark is between 450,000 DKK to 700,000 DKK per year. This salary range can vary depending on factors such as experience, education, and the specific industry or company the specialist is working in. Salaries may also be higher in larger companies or in highly regulated industries such as healthcare or pharmaceuticals.

Novo Nordisk AS engages in the research, development, manufacture, and marketing of pharmaceutical products. It operates through the Diabetes and Obesity Care; and Biopharmaceuticals segments. The Diabetes and Obesity Care segment covers insulins, glucagon-like-peptide 1, other protein-related products, oral anti-diabetic drugs and obesity. The Biopharmaceuticals segment handles the research, development, manufacture, and distribution of products within the areas of haemophilia, growth hormone, hormone replacement, inflammation and other therapy areas.