Regulatory Affairs Specialist

Welcome to Novo Nordisk! We are a global healthcare company dedicated to improving the lives of people living with chronic diseases. Our team is growing and we are currently seeking a highly motivated Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist at Novo Nordisk, you will play a crucial role in ensuring compliance with regulatory requirements and contributing to the development and approval of our life-changing therapies. We are looking for a detail-oriented and passionate individual with a strong understanding of regulatory affairs and experience in the pharmaceutical or biotech industry. If you are ready to make a difference and be a part of a dynamic and innovative company, we encourage you to apply for this exciting opportunity.

1. Ensure compliance with regulatory requirements: The primary responsibility of the Regulatory Affairs Specialist is to ensure that the company follows all relevant laws, regulations, and guidelines related to the development, manufacturing, and marketing of pharmaceutical products.
2. Develop and maintain regulatory strategies: The Specialist will be responsible for developing and implementing strategies to obtain regulatory approvals for new products and maintain existing product licenses.
3. Collaborate with cross-functional teams: The role requires working closely with various departments such as research and development, quality assurance, and marketing to ensure that regulatory requirements are met throughout the product lifecycle.
4. Prepare and submit regulatory submissions: The Specialist will be responsible for preparing and submitting regulatory documents, such as marketing authorization applications, to health authorities in a timely and accurate manner.
5. Provide regulatory guidance and support: The Specialist will act as a subject matter expert and provide guidance to internal teams on regulatory requirements and processes.
6. Monitor changes in regulations: The Specialist will keep up-to-date with changes in regulatory requirements and communicate any potential impacts to relevant stakeholders.
7. Conduct regulatory research and analysis: The role involves conducting research on new and existing regulations and analyzing their potential impact on the company's products and processes.
8. Participate in regulatory inspections and audits: The Specialist will help prepare for and participate in regulatory inspections and audits to ensure compliance with applicable regulations.
9. Maintain regulatory documentation: The Specialist will be responsible for maintaining accurate and up-to-date regulatory documentation, including submissions, approvals, and correspondence with health authorities.
10. Stay informed about industry developments: The Specialist will stay informed about industry trends and developments related to regulatory affairs and share relevant information with the team.
11. Uphold company values and standards: The Specialist will uphold the company's values and standards, including ethical conduct, integrity, and compliance with all applicable laws and regulations.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Plainsboro Township, NJ, USA is $85,000 - $115,000 per year. This can vary depending on the specific company, experience level, and education of the individual.

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.