JOB TITLE: Senior Regulatory Compliance Specialist DEPARTMENT: Quality
REPORTS TO: Quality Leadership EMPLOYEE STATUS: Exempt
LOCATION: Onsite WORK AVAILABLE: Full Time
JOB SUMMARY:
As a Senior Regulatory Compliance Specialist at Mark Cuban Cost Plus Drug Company, you will be trusted to provide expert regulatory oversight across all business units, including generic drug development (ANDAs), new drug applications (NDAs), 503B sterile compounding operations, and commercial wholesale pharmacy distribution. This role works closely with Regulatory Leadership to ensure strict compliance with FDA regulations, state boards of pharmacy, DSCSA guidelines, cGMPs, and USP standards while driving regulatory strategy across manufacturing, distribution, and commercial operations.
KEY RESPONSIBILITIES:
- Leads regulatory compliance strategies and oversight across all Mark Cuban Cost Plus Drug Company business units, including ANDAs, NDAs, 503B outsourcing facility compounding, and commercial wholesale distribution operations.
- Authors, reviews, and manages FDA regulatory submissions, amendments, supplements (CBE-30, PAS), annual reports, and lifecycle documentation for ANDA and NDA portfolios.
- Coordinates state board of pharmacy licensing, wholesale distributor registrations, DEA controlled substance registrations, and 503B facility listings across all operating jurisdictions.
- Authors reviews, and approves critical regulatory documentation, including product labeling, artwork, product specifications, standard operating procedures (SOPs), and facility policies.
- Oversees Drug Supply Chain Security Act (DSCSA) compliance, product serialization, verification, and wholesale distribution regulatory requirements.
- Leads regulatory audit and inspection readiness programs, hosting agency officials during FDA, state board, DEA, and third-party inspections, while directing post-inspection remediation plans.
- Acts as Subject Matter Expert (SME) on 21 CFR (Parts 207, 210, 211, 314), cGMPs, USP <795>/<797>, and FDA guidance documents, delivering regulatory interpretation and cross-functional training.
- Manages product listing lifecycle tasks, including GTIN and NDC creation, structured product labeling (SPL) submissions, and FDA drug shortage reporting.
- Directs regulatory risk assessments and investigations for non-conformances, customer complaints, field alerts, product recalls, and CAPAs.
- Monitors evolving federal and state pharmacy regulations, advising leadership on regulatory impacts to business expansion and product portfolio strategies.
EDUCATION / TRAINING:
- Bachelor's Degree in Regulatory Affairs, Pharmacy, Chemistry, Life Sciences, or equivalent years of directly related experience.
- Regulatory Affairs Certification (RAC) or applicable industry professional compliance certification preferred.
- Extensive knowledge of FDA regulatory requirements (21 CFR Parts 207, 210, 211, 314), cGMPs, DSCSA, and USP Sterile/Non-sterile Compounding (<797>/<795>) guidelines.
- Strong proficiency in state pharmacy board regulations, wholesale distribution licensing, and DEA compliance standards.
- Project Management proficiency and/or experience with Operational Excellence methodology.
- Proficient in regulatory publishing software, eCTD tools, and MS Office applications.
- Excellent data analytics, critical thinking, risk assessment, and decision-making concepts.
- Advocate for exceptional regulatory integrity, patient safety, and quality standards—does not compromise compliance expectations.
- Excellent written and verbal communication skills.
WORK EXPERIENCE:
- 5+ years of relevant regulatory affairs and compliance experience operating in an FDA-regulated pharmaceutical environment.
- Hands-on regulatory experience supporting ANDA/NDA submissions, 503B outsourcing facility compounding operations, or commercial pharmaceutical wholesale distribution.
- Direct experience leading FDA regulatory filings, state wholesale distribution licensing, and handling agency inspections.
- Demonstrated expertise orienting, training, and reviewing the work of peers and cross-functional teams.
- Computer literacy in Windows, Mac environments, eCTD software, and Quality Management Systems (QMS).
- Ability to establish and maintain effective working relationships with staff, senior management, cross-functional business units, and regulatory authorities.
ADDITIONAL QUALIFICATIONS (OPTIONAL):
- Ability to work independently with little to no supervision in a multi-facility, matrixed environment.
- Passion for transforming pharmaceutical supply chain transparency and expanding patient access to affordable medications.