The Regulatory and Compliance Specialist is responsible for initial new product assessment, confirming authorized distributors, NDC assignment, Structured Product Labeling (SPL’s), FDA registrations, Licensing and reporting.
Monday-Friday 8:00am-5:00pm
$32.00-$34.00/hour
Responsibilities:
Responsible for maintaining an accurate database of the status of all NDC’s currently assigned and assign new NDC’s as necessary.
Own new product review process to include manufacturer, and product approval, SPL required information, PPE requirements, required cleaning validation rating, hazardous waste impact and safety concerns.
Ensure receipt of current authorized distributor of record (ADR) certificates from all product suppliers.
Prepare Structured Product Labeling (SPL) for new products and communicate cross functionally of posted SPL’s.
Review ongoing product labeling to ensure compliance.
Maintain current knowledge of current SPL related regulations and requirements and communicate same to appropriate stakeholders.
Responsible for electronically reporting all potential FAERS adverse events.
Prepares and submits all required FDA and regulatory reports including: GDUFA, Establishment Registration and SPL Annual Certification.
Responsible for maintaining data on all controlled substances as required for quarterly and annual DEA Arcos submissions.
Prepare and submit DEA Form 106 for potentially lost/stolen controlled products.
Completes and submits data required for the U.S. Dept. of Commerce Census Report.
Monitor/renew state licenses (Wholesale/Manufacture/Controlled) as required.
Identify modifications for all required licenses and/or registrations in order to maintain corporate compliance with all pertinent agencies.
Prepare Foreign Corporation Registration and annual report submissions for each required state.
Maintain current knowledge of regulatory requirements/changes that impact and communicate to Management.
Responds to and interfaces with Regulatory Body as required.
Participates in, and provides support as needed to other regulatory affairs, regulatory compliance activities as the relate to the department and the company as a whole.
Read, understand and abide by written instructions and SOPs.
Requirements:
Bachelors Degree
5+ years of pharmaceutical regulatory experience
Proficient in MS Office
Able to comprehend and analyze technical documents
RAC (Regulatory Affairs Certification) a plus
