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The 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)
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. $58,900.00 - $72,200.00
Seniority level
Seniority level
Entry level
Employment type
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Job function
LegalIndustries
Medical Equipment Manufacturing
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