Regulatory Information Specialist

We are looking for a highly-motivated and detail-oriented Regulatory Information Specialist to join our team at the Food and Drug Administration (FDA). The Regulatory Information Specialist will play a key role in our mission to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. This position requires a combination of research, analysis, and writing skills, and the ability to work independently on multiple projects in a fast-paced environment. The ideal candidate will have a Bachelor’s degree in a relevant field, such as regulatory affairs or public health, along with a minimum of two years of related experience. A strong understanding of FDA regulations and their application to product development and marketing is essential for success in this role. If you have the qualifications we seek and the desire to make a real impact on public health, we invite you to apply!

Responsibilities:

1. Conduct research and analysis of current FDA regulations and their application to product development and marketing
2. Develop and update FDA regulations related to product development and marketing
3. Monitor and track new and pending FDA regulations for potential impacts on product development and marketing
4. Create reports and documentation related to FDA regulations and their application to product development and marketing
5. Present research findings and recommendations to stakeholders
6. Collaborate with internal and external teams to ensure compliance with FDA regulations
7. Respond to inquiries related to FDA regulations
8. Develop and maintain an understanding of FDA requirements and expectations
9. Develop training materials and provide training for internal teams on FDA regulations
10. Assist in the development of policies and procedures related to FDA regulations
11. Monitor industry trends and stay up to date on new developments in the FDA regulatory environment
12. Participate in meetings and other activities related to FDA regulations

According to JobzMall, the average salary range for a Regulatory Information Specialist in Silver Spring, MD, USA is between $45,000 and $85,000 per year. This range varies based on experience, qualifications, and other factors.

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.