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Director – Regulatory Affairs & Licensing

Primary Location Minneapolis-St. Paul-Bloomington, Minnesota Job ID R100553 Apply

The Director of Regulatory Affairs and Licensing is part of the Compliance & Regulatory organization and reports directly to the VP of Regulatory Operations.  This position is accountable for providing leadership and direction in the development and implementation of regulatory strategies and programs ensuring that the Company’s operations comply with Federal, State, and Local governmental regulations and company policies related to the sale and distribution of regulated products.  This position is responsible for developing, implementing, maintaining and managing regulatory programs and initiatives including comprehensive licensing, due diligence and accreditation programs that drive a culture of compliance.

Responsibilities

  • Provide leadership in the development and implementation of current and future facility and customer licensing strategies to support the achievement of business objectives, while ensuring compliance with government regulations.

  • Lead licensing and accreditation efforts focused on training, communication, auditing & monitoring and overall continuous improvement efforts.      

  • Develop and lead sustainable facility licensing strategy and staffing plan to optimize current licensure footprint and support current and future commercial operations.

  • Evaluate existing regulatory processes and identify opportunities to implement, improve and maintain processes and systems to ensure compliance with government regulations and company policies.    

  • Partner with regulatory and business unit leadership to identify opportunities to educate employees about regulatory initiatives and develop internal communications to build general awareness about the importance of compliance. 

  • Coordinate with various internal departments to help ensure they are meeting new or existing laws and regulations as well as company, customer and accreditation requirements.

  • Develop and maintain subject matter expertise on legislative and regulatory requirements affecting dispensing and wholesale distribution of pharmaceutical products to include DEA controlled substances.

  • Research and monitor changes to laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies and/or a work plan and complete according to deadlines. 

  • Triage regulatory issues that are escalated and provide consultative guidance to internal partners. 

  • Act as liaison between company and health authorities for assigned programs.  Interact effectively with various internal and external departments and leaders to provide guidance, information and assistance.

  • Provide leadership to ensure the Regulatory organization attracts, develops and retains the best people and fosters an environment that motivates a diverse team to fully use its capabilities in achieving desired business results.

  • Encourage the growth of all direct and indirect reports through skill development and goal setting.

  • Hold direct reports accountable for meeting performance standards and departmental performance goals.

Minimum Qualifications:

  • Bachelor’s degree

  • A minimum of 12+ years of experience working in the Regulatory, Compliance or Risk Management fields, and 6+ years of previous supervisory and management experience successfully leading and developing a team.

  • Knowledge of pharmaceutical distribution regulations (e.g. FDA, DEA, State BOP’s, NABP Drug Distributor Accreditation, etc.).

  • Experience successfully developing, managing and driving execution of programs collaboratively in a highly matrixed environment.

  • Experience with project management, including developing work plans, assigning and partnering on tasks, completing milestones in a structured cadence, and tracking deadlines.

  • Strong written, verbal, and interpersonal communication skills with a collaborative and energetic style, comfortable with remote site communications and effectively communicating with all levels of an organization, including senior leadership.

  • Strong analytical and organizational skills.

  • Ideal candidate will demonstrate strong bias towards action and results-orientation while being highly collaborative

Preferred Qualifications

  • Law degree

  • Experience researching and interpreting regulatory requirements.

  • Experience working in pharmaceutical distribution, pharmacy or a similar field.

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  • Regulatory Group, Minneapolis-St. Paul-Bloomington, Minnesota, United StatesRemove

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