Southend Pharmacy · 1 month ago
Director of Regulatory Affairs & Compliance
Houston, TX, US
Full-time
Onsite
Director/Executive
$160K/yr - $180K/yr
7+ years expSouthend Pharmacy is a 503A compounding pharmacy seeking a Director of Regulatory Affairs & Compliance to lead regulatory, licensing, and compliance functions. This role involves ensuring adherence to pharmacy laws and standards, overseeing compliance programs, and collaborating with operational teams to maintain quality and safety.
Retail
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
Qualification
Required
Bachelor's degree in Pharmacy, Regulatory Affairs, Life Sciences, or related field
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
Preferred
PharmD or advanced degree preferred
Certification in Regulatory Affairs (RAC) or Compliance (CHC/CCEP) preferred
Company
Southend Pharmacy
Southend Pharmacy offers healthcare providers a partnership that extends beyond the script, delivering innovative care solutions and seamless support.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase