Senior Regulatory Affairs Leader — FDA, DSCSA & 503B

Mark Cuban Cost Plus Drug Company; Dallas (TX); Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

FDA regulations

Project management

eCTD tools

SOP writing

Ausbildung

Bachelor's degree in Regulatory Affairs / Life Sciences

Tools

MS Office

eCTD software

Jobbeschreibung

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