Senior Regulatory Compliance Specialist - Dallas, Texas

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 on behalf of a fast-growing online pharmacy company to provide regulatory oversight across pharmaceutical development, 503B sterile compounding, wholesale distribution, and commercial operations. This senior-level role will lead regulatory strategy, submissions, licensing, inspection readiness, and compliance programs while partnering closely with regulatory leadership and cross-functional teams to protect patient safety and maintain the highest quality standards.

Responsibilities

• Lead regulatory compliance strategy and oversight across ANDA, NDA, 503B outsourcing facility compounding, and pharmaceutical wholesale distribution operations.
• Author, review, and manage FDA regulatory submissions, amendments, supplements, annual reports, and lifecycle documentation for ANDA and NDA portfolios.
• Coordinate state board of pharmacy licenses, wholesale distributor registrations, DEA controlled substance registrations, and 503B facility listings across operating jurisdictions.
• Author, review, and approve regulatory documentation, including product labeling, artwork, specifications, SOPs, and facility policies.
• Oversee DSCSA compliance, including product serialization, verification, and wholesale distribution requirements.
• Lead audit and inspection readiness activities and host FDA, state board of pharmacy, DEA, and third-party inspections.
• Develop and direct post-inspection remediation plans, including corrective actions and follow-up activities.
• Serve as a subject matter expert on 21 CFR Parts 207, 210, 211, and 314; cGMP requirements; USP <795> and <797>; and applicable FDA guidance.
• Deliver regulatory interpretation, training, and guidance to cross-functional teams.
• Manage product listing lifecycle activities, including GTIN and NDC creation, Structured Product Labeling submissions, and FDA drug shortage reporting.
• Lead regulatory risk assessments and investigations related to nonconformances, complaints, field alerts, recalls, and CAPAs.
• Monitor evolving federal and state pharmacy regulations and advise leadership on impacts to business expansion and product portfolio strategy.

Requirements

• Bachelor's degree in Regulatory Affairs, Pharmacy, Chemistry, Life Sciences, or equivalent directly related experience.
• 5+ years of regulatory affairs and compliance experience in an FDA-regulated pharmaceutical environment.
• Hands-on experience supporting ANDA or NDA submissions, 503B outsourcing facility compounding operations, or commercial pharmaceutical wholesale distribution.
• Direct experience with FDA regulatory filings, state wholesale distribution licensing, and regulatory agency inspections.
• Extensive knowledge of FDA requirements, including 21 CFR Parts 207, 210, 211, and 314; cGMPs; DSCSA; and USP <795> and <797> standards.
• Strong knowledge of state pharmacy board regulations, wholesale distribution licensing, and DEA compliance requirements.
• Experience authoring, reviewing, and approving regulatory documentation and regulatory submissions.
• Experience leading, training, and reviewing the work of peers and cross-functional teams.
• Proficiency with regulatory publishing software, eCTD tools, Quality Management Systems, and Microsoft Office applications.
• Strong project management, analytics, critical thinking, risk assessment, and decisionmaking skills.
• Excellent written and verbal communication skills and the ability to build effective working relationships with senior leadership, cross-functional teams, and regulatory authorities.
• Commitment to regulatory integrity, patient safety, and quality standards.
• Ability to work independently with minimal supervision in a multi-facility, matrixed environment.
• Regulatory Affairs Certification (RAC) or a comparable professional compliance certification is preferred.