Regulatory Compliance Manager

Position responsibilities:

• Monitor, review, and interpret regulatory updates from federal and state agencies, including VAWD, DSCSA, and NABP requirements. Provide regulatory recommendations and training to various departments.

• Lead internal and external audits, including regulatory inspections (FDA, Board of Pharmacy), and develop corrective actions/remediation plans. Conduct mock audits, manage audit evidence, and ensure timely follow-up on compliance findings.

• Design and manage compliance training programs for employees, particularly on VAWD/DSCSA regulations, FDA inspections, and Board of Pharmacy laws. Train operations managers on designated rep requirements.

• Oversee the licensing process for facilities, customers, and vendors. Manage the recall compliance process, ensuring efficiency both internally and with external partners.

• Ensure all requirements for onboarding new accounts are met, including accurate completion of forms and compliance with regulatory requirements.

• Conduct transactional monitoring, identify trends, and provide reports to executive leadership on compliance-related activities. Oversee and validate all compliance processes to ensure adherence to regulations.

• Support large-scale projects by developing business requirements, providing documentation, managing communication across teams, and tracking project progress.

• Manage HIPAA-related processes, including the review of new accounts for BA agreements, and lead companywide HIPAA training.

• Collaborate with the CFO to develop business continuity strategies and ensure processes are in place to maintain compliance in emergency situations.

Minimum Requirements:

• Bachelor's degree or equivalent combination of education and experience.
• 5-8 years of healthcare regulatory compliance or privacy experience.
• Strong understanding of relevant laws and regulations
• Strong ability to handle multiple tasks with competing deadlines.
• Proven leadership and managerial skills, with the ability to motivate and coach direct and indirect reports.
• Excellent communication skills, both written and verbal, with the ability to present regulatory updates clearly.
• High degree of integrity and strong business ethics.