Regulatory and Compliance Manager

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