Senior Regulatory Licensing Specialist

The Senior Regulatory Licensing Specialist is responsible for managing a diverse portfolio of wholesale distributor and pharmaceutical licenses across the United States and Canada. This role handles complex licensing issues, conducts regulatory research, and ensures timely license renewals for assigned portfolio. This role requires close collaboration with state and federal regulatory agencies and internal stakeholders.

Essential Functions

Oversee a portfolio of licenses for wholesale distributors, third-party logistics providers, and pharmacies, for new and/or renewals of license/registration applications (including, FDA, DEA, and State Boards of Pharmacy, and NABP) in adherence to strict requirements and deadlines ensuring compliance with local, state and federal regulations

Resolve complex issues related to license applications, renewals, and compliance with regulatory requirements

Research and interpret licensing compliance related laws and regulations; make recommendations, decisions, and/or advice cross-functionally to maintain compliance with federal, state, and local regulations

Maintain responsibility for on-time renewal of licenses/registrations within assigned portfolio; prepare documentation in adherence to strict requirements and deadlines

Represent the organization and collaborate with federal, state, or local regulatory agencies (e.g., Board of Pharmacy, DEA, FDA, Department of Agriculture) to address inquiries and ensure compliance

Serve as a resource for internal stakeholders regarding licensing matters and regulatory compliance; partner cross-functionally to address issues and/or communication needs

Oversee, and lead, the accreditation processes (i.e., National Association of Boards of Pharmacy (NABP)) and facilitate information gathering and facilities inspections between NABP representative and internal teams as needed

Develop, document, and/or evaluate internal processes and reports and recommend enhancements to streamline workflow while ensuring compliance with regulatory and company requirements

Maintain licensing and application data within required systems to track application results, permits, and accreditations to include agency, renewal dates and other related data

Comply with Company and department policies and standards; performs other duties as assigned

Minimum Requirements

Bachelor's Degree in Business or related field or equivalent education and/or experience

5 years of experience in a regulatory or compliance-focused role, preferably in a healthcare or pharmaceutical setting

Experience working with regulators in various state or federal regulatory agencies

Skills and Abilities

Excellent verbal and written communication skills with the ability to effectively communicate complex regulatory information

Time management skills to meet deadlines; ability to prioritize, multi-task and adapt to changing priorities

Strong analytical, attention to detail, and problem-solving skills

Knowledge of regulatory compliance and licensing laws and regulations; strong legal research skills and ability to interpret complex laws and regulations

Highly deadline driven and self-motivated, with a strong sense of accountability to complete work timely

Proficient with Microsoft Office Suite (SharePoint, Word, Excel, PowerPoint, Outlook)

Physical and Cognitive Demands

Communicate/Hearing Frequently

Communicate/Talking Frequently

Learn New Tasks or Concepts Frequently

Make Timely Decisions in the Context of a Workflow Frequently

Complete Tasks Independently Constantly

Maintain Focus Constantly

Remember Processes & Procedures Constantly

Stationary Position (Seated) Constantly

Vision Constantly

The potential compensation range for this role is below. The final offer amount would be based on various factors such as candidate location (geographical labor market), experience, and skills. $85,500.00 - $106,800.00

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