Senior Regulatory Compliance Specialist

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.

• 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.

• 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 decision-making 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.

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