Regulatory Affairs Specialist

Do you have a passion for ensuring the safety and compliance of pharmaceutical products? Are you a detail-oriented and proactive individual with experience in regulatory affairs? If so, we have an exciting opportunity for you to join our team at Novo Nordisk as a Regulatory Affairs Specialist. As a global leader in diabetes care, we are committed to delivering innovative and life-changing treatments to patients worldwide. Join us in our mission to make a difference and improve the lives of millions. Read on to learn more about this role and the qualifications we are looking for in our ideal candidate.

1. Develop and maintain an in-depth understanding of global pharmaceutical regulations and guidelines to ensure compliance in all aspects of drug development, manufacturing, and distribution.
2. Review and assess all relevant regulatory submissions, including new drug applications, marketing authorization applications, and variations, to ensure accuracy and completeness.
3. Collaborate with cross-functional teams, including Quality, Research and Development, and Clinical Operations, to provide regulatory guidance and support throughout the drug development process.
4. Proactively identify potential regulatory issues or obstacles and develop strategies to mitigate risks and ensure timely approvals.
5. Keep abreast of changes in regulations and guidelines and communicate potential impact to the organization.
6. Prepare and submit regulatory documents and reports to health authorities in accordance with established timelines and requirements.
7. Participate in regulatory agency meetings and negotiations as needed.
8. Maintain accurate and up-to-date records of all regulatory activities and submissions.
9. Contribute to the development and implementation of company-wide regulatory processes and procedures.
10. Serve as a subject matter expert on regulatory affairs, providing guidance and training to internal teams.
11. Ensure compliance with company policies and procedures, as well as industry standards and regulations.
12. Represent the company in a professional manner and uphold the company's mission and values.
13. Continuously seek opportunities for process improvement and efficiency in regulatory processes.
14. Maintain confidentiality of all sensitive information and adhere to ethical standards in all aspects of the job.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Hauppauge, NY, USA is between $70,000 and $95,000 per year. However, this may vary depending on factors such as experience, education, and specific job responsibilities.

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.