The 503B Regulatory Affairs Specialist I is accountable for driving results in a fast-paced regulated environment. Responsible for ensuring that the 503B Outsourcing Facility is appropriately registered/licensed and complies with the requirements for labeling, reporting, and permissible products of the Compounding Quality Act (Section 503B of the Food, Drug, and Cosmetic Act). The 503B Regulatory Affairs Specialist I will perform procurement quota applications and ARCOS reporting for controlled substances. This position requires superior leadership, organization, and attention to detail.

Responsibilities:

• Obtain and maintain 503B State licensing facility applications.


• Monitor FDA registration and State licensing regulations for 503B facilities.


• Verify State licenses during the 503B customer intake process.


• Review 503B labeling for compliance to the Compounding Quality Act.


• Assign NDC numbers for 503B products.


• Review Change Control Records for 503B products to ensure that the proposed products comply with the Compounding Quality Act.


• Submit biannual product listings to FDA.


• Obtain and maintain 503B registrations and licenses for the production of controlled substances.


• Submit procurement quota applications to the DEA for controlled substances.


• Submit ARCOS reports to the DEA for controlled substances.


• Assist Regulatory Affairs personnel with daily activities as necessary

Qualifications:

• Bachelor of Science degree, preferably in chemistry or biology, and at least one year professional experience in pharmaceuticals


• Understanding of FDA regulations


• General proficiency with MS office including word processing and database software


• A high level of integrity and attention to detail


• Must work efficiently with moderate supervision


• Excellent written and verbal communication skills and strong interpersonal skills