Manager, Regulatory & Compliance

Under general managerial direction from the Manager, Regulatory and Compliance, the incumbent manages the regulatory compliance process with focus on DEA, State Board of Pharmacy, FDA, EPA and OSHA. Performs in-depth review and inspection of all compliance policies and procedures to ensure minimal risk for Inmar while still allowing the warehouses to effectively conduct business and serve their Clients. Plans, coordinates, supervises and/or executes all aspects of Inmar’s Regulatory Compliance audit program and training for exempt and non-exempt personnel in the Facility.

Primary Accountabilities

Under general managerial direction from the Manager, Regulatory and Compliance, the incumbent provides regulatory support in all aspects of the Rx Solutions business. Individual must be driven and self motivated, with the ability to manage tasks with little or no upper management involvement. Performs in-depth review and inspection of all compliance policies and procedures to ensure minimal risk for Inmar while still allowing the warehouses to effectively conduct business and serve their Clients. Executes all aspects of Inmar’s regulatory compliance audit program and training for exempt and non-exempt personnel in the Facility. The position requires industry knowledge of the regulations that impact the business in areas such as DOT, FDA, EPA, OSHA, USDA, as well as the applicable state and territorial regulations, with a strong emphasis on DEA and State Board of Pharmacy regulations.

Project Management 25%

Conduct regulatory audits and analyze operational data to identify trends and potential regulatory issues.

Operational 25%

Execute the regulatory compliance audit program by performing the following: process reviews, internal audits, assist operations with developing and implementing corrective action plans, and preparing. Supervise operations during government or regulating entity inspections and support violation mitigation. Supervise the proper reporting of all regulatory reporting such as DEA forms, ARCOS transactions, OSHA records, EPA reports and Tier II reports.

Leadership 25%

Provide regulatory compliance direction to designated Inmar Center warehouse. Serve a resource to provide guidance and answer questions for managers and support partners, including assisting with the development / facilitation of training and the development and maintenance of regulatory compliance policies and procedures.

Strategic 15%

Developing relationships with inspecting regulatory agencies such as PHMSA (DOT), DEA, EPA, BOP, FDA/USDA, OSHA, etc. Monitor regulations for changes that may impact operations. Analyze operational data to identify trends and potential regulatory issues.

Administration 10%

Filing and note taking associated with Regulatory agency inspections, internal auditing and training. Timely response to standard regulatory agency requests.

Minimum Requirements

• Four year college degree preferred
• 6-8 years of regulatory experience is required
• Experience working with Board of Pharmacy and/or DEA regulations is preferred
• Travel of up to 25%-50%
  
  

Preferred Experience

• DEA Diversion experience is a strong preference
  
  

Individual Competencies

• Teamwork: Builds relationships and works cooperatively with others, inside and outside the organization, to accomplish objectives to build and maintain mutually-beneficial partnerships, leverage information and achieve results.
• Analytical and Critical Thinking: Ability to tackle a problem by using a logical, systematic, sequential approach.
• Effective Execution: Translates broad conceptual understanding of the company's strategy into a tactical plan of how it will happen including who will take on which tasks in what sequence, how long those tasks will take, how much the tasks cost, and how each task affects subsequent activities.
  
  

The physical demands described here are representative of those that must be met by an associate to successfully perform the major job responsibilities (essential functions) of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the major job responsibilities. This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job.

While performing the duties of this job, the associate is:

• Occasionally required to use hands to finger, handle or feel objects, tools or controls, and reach with hands or arms.
• Regularly required to talk or hear and read instructions on a computer monitor and/or printed on paper.
• Occasionally required to stand, kneel or stoop, and lift and/or move up to ## pounds.
• Occasionally required to view items at an extremely close range and must be able to adjust and readjust focus.
  
  

We are an Equal Opportunity Employer, including disability/vets.