Senior Regulatory Compliance Specialist

Mark Cuban Cost Plus Drug Company; Dallas (TX); On-site; USD 140,000 - 190,000; Full time

Job summary

Mark Cuban Cost Plus Drug Company in Dallas, TX is seeking a Senior Regulatory Compliance Specialist to oversee regulatory affairs across all business units, including ANDAs, NDAs, 503B operations, and wholesale distribution. You will partner with Regulatory Leadership to ensure FDA, state boards, DSCSA, cGMPs, and USP standards.

The ideal candidate will bring 5+ years of FDA-regulated pharma compliance experience, RAC or similar certification, strong analytical skills, and the ability to train

Qualifications

• Bachelor's degree in regulatory affairs, pharmacy, chemistry, life sciences, or equivalent years of related experience.
• Regulatory Affairs Certification (RAC) preferred.
• Extensive knowledge of FDA requirements (21 CFR Parts 207, 210, 211, 314), cGMPs, DSCSA, USP guidelines.
• Strong knowledge of state boards, wholesale distribution licensing, and DEA standards.

Responsibilities

• Leads regulatory strategies across ANDAs, NDAs, 503B operations, and wholesale distribution.
• Manages FDA submissions, amendments, supplements, and lifecycle documentation for regulatory portfolios.
• Coordinates licensing, registrations, and facility listings across jurisdictions.
• Authors and approves labeling, artwork, SOPs, and facility policies.
• Oversees DSCSA compliance, serialization, verification, and distribution regulatory needs.
• Leads regulatory audit readiness and manages post-inspection remediation.

Skills

Regulatory affairs

FDA regulations

Project management

eCTD tools

SOP writing

Education

Bachelor's degree in Regulatory Affairs / Life Sciences

Tools

MS Office

eCTD software

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Regulatory Compliance Specialist

DARPA Professional Dallas, TX, US

3 days ago Requisition ID: 1023

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.