Manager, Regulatory & Compliance

Job Description

Job Description

Summary :

The Manager, Regulatory & Compliance will ensure all GSMS facilities and business entities maintain full compliance with all applicable federal and state regulatory requirements and guidelines for the manufacture, storage, distribution, marketing and sales of GSMS’ products and services. The Manager, Regulatory & Compliance will work with federal, state, and local regulatory agencies on registrations, licenses, and reporting related to GSMS’ products and services. The Manager, Regulatory & Compliance will assist the VP Quality & Compliance with the design, administration, and maintenance of GSMS’ Corporate Compliance Plan, Code of Conduct, and associated Compliance Policies & Procedures.

Experience :

Bachelor’s degree with a minimum 6 years of experience in pharmaceutical regulatory & compliance operations, and 2 years of Supervisory experience required.

General Duties and Responsibilities :

• Manage federal registrations, licenses, and regulatory reporting to FDA, DEA, and other applicable federal agencies.
• Manage US State licenses and applicable state reporting for pharmaceuticals, controlled substance, price transparency, etc. as required by state regulations.
• Responsible for the oversight and management of GSMS contracted state registered agents.
• Responsible for management and oversight of GSMS National Drug Code (NDC) directory.
• Responsible for management and oversight of GSMS Structured Product Labeling (SPL)
• Responsible for Regulatory & Compliance professional certifications and memberships, such as National Association of Boards of Pharmacy (NABP), Pharmaceutical Product Stewardship Work Group (PPSWG), etc.
• Responsible for the design, implementation, and maintenance of GSMS Regulatory Intelligence Framework to ensure continued compliance with new federal and state regulations and regulatory trends.
• Develop, implement, and maintain policies and procedures related to new GSMS business opportunities to ensure compliance with applicable federal and state regulations.
• Responsible for GSMS corporate compliance and healthcare compliance programs for items such as ethics, fraud, anti-kickback, conflict of interest, HIPPA, US federal Sunshine Act, state disclosure, etc
• Responsible for the compliance and accuracy of GSMS promotional activities and materials.
• Create, execute, and monitor GSMS Compliance Training Program, including the development of role-based training curriculum and training content.
• Assists the VP Quality and Compliance with the design, administration, and maintenance of GSMS Corporate Compliance Plan, Code of Conduct, and associated Compliance Policies & Procedures.
• Responsible for the execution of the Corporate Compliance Committee under oversight of the VP Quality & Compliance.
• Responsible for ensuring Compliance Policies and Procedures are compliant and up to date with applicable regulations.
• Own and execute GSMS Corporate Audit Program to ensure compliance with all applicable regulations and corporate policies / procedures.
• Provide supervision, coaching, development and performance reviews for corporate regulatory / compliance staff
• Participates in special projects and performs other duties as assigned.

Required Qualifications :

Miscellaneous Requirements :

At Golden State Medical Supply (GSMS), we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at humanresources@gsms.us. GSMS will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.”