In-depth knowledge of pharmaceutical regulations, including manufacturing, storage, and distribution requirements
Familiarity with FDA regulations such as NDC, SPL, GDUFA, and CARES Act reporting
Understanding of healthcare compliance laws (e.g., Sunshine Act, False Claims Act, Anti-kickback Statute)
Strong communication skills, both written and verbal
Ability to interpret complex regulations, legal and technical documents
Excellent organizational skills and attention to detail
Strong analytical and problem-solving skills
Ability to manage multiple projects and deadlines
Effective team leadership and collaboration skills
Proficiency in Microsoft Office tools
Manage federal registrations, licenses, and regulatory reporting with agencies such as FDA and DEA
Oversee state licensing and reporting requirements related to pharmaceuticals, controlled substances, and price transparency
Manage relationships with state-registered agents
Maintain oversight of the National Drug Code (NDC) directory and Structured Product Labeling (SPL)
Maintain certifications and memberships with professional regulatory organizations (e.g., NABP, PPSWG)
Design and manage a Regulatory Intelligence Framework to ensure compliance with evolving regulations
Develop and implement policies and procedures to support new business initiatives in compliance with regulatory standards
Lead corporate and healthcare compliance efforts, including areas such as ethics, fraud prevention, anti-kickback, conflict of interest, HIPAA, Sunshine Act, and state disclosure laws
Review and ensure compliance of promotional materials and marketing activities
Develop and manage a comprehensive Compliance Training Program, including role-specific training content
Support administration of the Corporate Compliance Plan and assist in compliance committee operations
Conduct internal audits to assess and ensure regulatory and corporate policy compliance
Supervise and develop regulatory/compliance team members
Participate in special projects and additional duties as assigned
Miscellaneous Requirements:
Must pass background check and drug screening
Must comply with drug-free workplace policies