Regulatory Affairs Specialist

Welcome to Novo Nordisk! We are a global healthcare company dedicated to improving the lives of people living with chronic diseases. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our products meet all regulatory requirements and are safe for our patients. We are seeking a highly organized and detail-oriented individual with a strong understanding of regulatory affairs and a passion for making a positive impact in the healthcare industry. If you are looking for a challenging and rewarding career with a company that values innovation and patient well-being, we encourage you to apply for this position.

1. Develop and maintain a thorough understanding of global regulatory requirements for pharmaceutical products, including but not limited to FDA, EMA, and other international agencies.
2. Ensure compliance with all applicable regulations and guidelines for the development, registration, and commercialization of Novo Nordisk products.
3. Serve as the primary point of contact for regulatory agencies and communicate with them on behalf of Novo Nordisk.
4. Prepare and submit regulatory filings, including new drug applications, supplements, variations, and annual reports.
5. Conduct regulatory assessments and provide guidance to cross-functional teams on regulatory requirements and potential risks.
6. Collaborate with internal teams such as R&D, clinical development, quality assurance, and marketing to gather information and documentation for regulatory submissions.
7. Track and maintain records of all regulatory submissions and approvals.
8. Monitor and analyze changes in regulatory requirements and communicate updates to relevant stakeholders.
9. Participate in internal and external audits and inspections related to regulatory affairs.
10. Assist in developing and implementing regulatory strategies for new and existing products.
11. Identify and communicate potential regulatory issues and provide recommendations for resolution.
12. Participate in cross-functional meetings and provide regulatory input and advice.
13. Develop and maintain relationships with key stakeholders and regulatory agencies.
14. Keep abreast of industry developments and proactively identify opportunities for process improvements.
15. Maintain confidentiality and adhere to all company policies and procedures.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Princeton, NJ, USA is $79,000 - $102,000 per year. However, this can vary depending on the specific company, level of experience, and individual qualifications.

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.