Senior Regulatory Compliance Leader – Pharma & 503B

MissionHires; Dallas (TX); On-site; USD 130,000 - 180,000; Full time

Job summary

MissionHires is seeking a Senior Regulatory Compliance Specialist for a fast-growing online pharmacy company in Dallas, TX to oversee regulatory programs across development, 503B compounding, wholesale distribution, and commercial operations.

You will lead submissions, licensing, inspection readiness, and regulatory strategy, partnering with leadership and cross-functional teams to ensure patient safety and quality.

Qualifications

• Bachelor's degree in Regulatory Affairs, Pharmacy, Chemistry, Life Sciences, or related field.
• 5+ years of regulatory affairs and compliance experience in FDA-regulated environments.
• Experience supporting ANDA/NDA submissions and 503B operations.
• Direct experience with FDA filings, licensing, and inspections.
• Strong knowledge of 21 CFR Parts 207, 210, 211, and 314; DSCSA and cGMPs.
• Experience with state pharmacy boards, wholesale distribution licensing and DEA.
• Proficiency with regulatory publishing software and MS Office.
• Ability to work independently in a multi-facility environment.
• Regulatory Affairs Certification (RAC) preferred.

Responsibilities

• Lead regulatory strategy and oversight across drug development, 503B, and wholesale distribution.
• Author and manage FDA submissions, amendments, and annual reports.
• Coordinate licenses and registrations across jurisdictions.
• Review regulatory documentation, labeling, SOPs, and facility policies.
• Oversee DSCSA compliance and product serialization.
• Lead inspections and remediation planning post-audit.
• Provide regulatory guidance to cross-functional teams.
• Monitor evolving federal and state regulations and advise leadership.
• Manage product listings including GTIN, NDC, and drug shortage reporting.
• Drive risk assessments and CAPA investigations.

Skills

Regulatory affairs

FDA regulations

cGMP

Regulatory submissions

Risk assessment

Cross-functional leadership

Documentation & labeling

eCTD tools

Education

Bachelor's degree in Regulatory Affairs or related field

Tools

Regulatory publishing software

eCTD tools

Quality Management System (QMS)

Microsoft Office

Job description

MissionHires is seeking a Senior Regulatory Compliance Specialist for a fast-growing online pharmacy company in Dallas, TX to oversee regulatory programs across development, 503B compounding, wholesale distribution, and commercial operations.

You will lead submissions, licensing, inspection readiness, and regulatory strategy, partnering with leadership and cross-functional teams to ensure patient safety and quality.