The Regulatory and Compliance Specialist is responsible for initial new product assessment, confirming authorized distributors, NDC assignment, Structured Product Labeling (SPL’s), DEA Arcos Reporting, DEA Class II Quota, FDA registrations, Licensing and reporting.

General Duties and 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
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.

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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