Director of Regulatory Affairs & Compliance

AP MAX INC•Houston, TX

29d

About The Position

The Director of Regulatory Affairs & Compliance provides executive-level leadership for all regulatory, licensing, and compliance functions within the 503A compounding pharmacy. This individual ensures that the organization maintains full adherence to federal, state, and local laws governing pharmacy practice, including USP <795>, USP <797>, and USP <800> standards, DEA regulations, FDA compounding guidance, and state board of pharmacy requirements. The Director is responsible for designing, implementing, and monitoring the pharmacy’s compliance framework, overseeing both the Regulatory Affairs and Compliance Teams. This role provides strategic oversight of regulatory submissions, audits, inspections, risk management, and internal policies ensuring operational readiness, patient safety, and corporate integrity.

Requirements

Bachelor’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or related field (PharmD or advanced degree preferred).
Minimum 7–10 years in regulatory/compliance roles within a compounding or pharmaceutical environment with at least 5 years in a leadership capacity.
Deep understanding of federal and state pharmacy laws, USP standards, and FDA guidance for 503A compounding.
Demonstrated success managing inspections by FDA, DEA, and state regulatory authorities.
Proven ability to interpret complex regulations and translate them into operational practice.
Experience developing and leading compliance training and risk management programs.
Strong leadership, communication, and analytical skills.
Ability to sit for extended periods of time at a desk and working on a computer.
Ability to communicate effectively in person, over the phone, or via virtual meeting
Ability to maintain focus in a typical office environment with moderate noise levels.
Ability to perform repetitive motions with hands and arms, such as typing.

Nice To Haves

Certification in Regulatory Affairs (RAC) or Compliance (CHC/CCEP) preferred.

Responsibilities

Serve as a primary point of contact with all regulatory and licensing agencies, including the FDA, DEA, and State Boards of Pharmacy across all jurisdictions where the pharmacy operates or ships.
Oversee and maintain all pharmacy, facility, and controlled substance licenses, ensuring timely renewal and compliance with multi-state regulatory requirements.
Interpret, implement, and communicate new or revised regulations, guidance documents, and compounding standards.
Develop strategies to maintain compliance with the Federal Food, Drug, and Cosmetic Act, Drug Quality and Security Act (DQSA), 503A provisions, all appropriate USP chapters and other applicable federal laws.
Prepare, submit, and manage all regulatory filings, including but not limited to FDA correspondence, controlled substance registration updates, state-specific renewals, disclosures, and applications.
Coordinate all regulatory inspections and audits, ensuring readiness, professional representation, and timely corrective action responses.
Monitor and assess federal and state regulatory developments affecting compounding practice, communicating key changes to leadership and operational teams
Lead the design and execution of a comprehensive corporate compliance program, including compliance governance, monitoring, auditing, and training.
Ensure company-wide adherence to internal policies and SOPs, ethical standards, and professional codes of conduct.
Oversee investigations of potential noncompliance issues, including documentation, root cause analysis, CAPA development, and follow-up verification.
Maintain HIPAA compliance and oversee privacy incident reporting and mitigation efforts.
Develop and manage DEA compliance programs including but not limited to controlled substance storage, recordkeeping, inventory reconciliation, and suspicious order monitoring.
Establish and maintain the OSHA and environmental health and safety (EHS) compliance programs, ensuring staff protection and workplace safety.
Implement proactive risk assessment programs to identify and mitigate operational and regulatory risks across departments.
Develop and deliver recurring compliance education and certification programs for staff and management.
Oversee the provider onboarding and credentialing process, ensuring all prescribers are properly verified, licensed, and compliant with federal and state prescribing requirements prior to engagement.
Collaborate with pharmacy operations and clinical teams to maintain a compliant and efficient provider onboarding workflow, including periodic re-verification of credentials and adherence to DEA and state scope-of-practice regulations.
Partner closely with the Director of Pharmacy Operations and Director of Quality Operations to ensure seamless compliance across compounding, packaging, labeling, and distribution workflows.
Participate in Quality Management System (QMS) development, ensuring compliance-related elements (audits, CAPAs, investigations, deviation management) are effectively integrated.
Review and approve SOPs, batch documentation, and labeling for compliance with USP and state/federal regulations.
Oversee documentation control, ensuring all compliance and regulatory records are complete, accurate, and audit-ready.
Support product recall or withdrawal processes, including notification, documentation, and coordination with regulatory bodies.