Regulatory Licensing Specialist
Primary Location Minneapolis-St. Paul-Bloomington, Minnesota Job ID R109970 ApplyThe Regulatory Licensing Specialist is responsible to determine, prepare, and submit required licensing in adherence with industry standards and protocols across the United States and Canada. This role is accountable to maintain knowledge of regulations, advise on changes, and provide reporting to ensure operational efficiency within regulatory compliance.
Essential Functions
Determine licensing and regulatory submissions required and prepare documentation for new and/or renewals of license/registration applications (including, FDA, DEA, and State Boards of Pharmacy) in adherence to strict requirements and deadlines
Facilitate registration and reporting activities for respective Federal, State and /or local agencies and accreditation boards as appropriate for license maintenance
Research and interpret licensing compliance related laws and regulations and make recommendations to leadership to ensure compliance based on regulation changes; advise cross-functionally to maintain compliance with federal, state and local licensing regulations
Represent the organization to regulatory agencies; develop and maintain professional relationships while working with regulators across various state or federal agencies
Maintain licensing and application data within required systems to track application results, permits, and accreditations to include agency, renewal dates, and other related data
Prepare and analyze reports for operational efficiency regulatory compliance; advise management of trends and opportunities
Act as a liaison for licensing-related issues and contribute to applicable communications; partner cross-functionally with field leadership and external agencies as appropriate
Develop, document, and/or evaluate internal processes and reports and recommend enhancements to streamline workflow while ensuring compliance with regulatory and company requirements
Collaborate and ensure effective communication across teams (i.e., Customer Service, Sales, Marketing, Purchasing, Logistics, Finance and Legal) for compliance needs
Assist with reporting and product registrations (i.e., pesticides, drugs, commercial feed) as necessary
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
2 years of experience in a regulatory or compliance-focused role, preferably in a healthcare or pharmaceutical setting
Preferred Requirements
3 years of experience in a regulatory or compliance-focused role, preferably in a healthcare or pharmaceutical setting
Skills and Abilities
Strong 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
Self-motivated and results-driven, 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. $60,400.00 - $74,000.00
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