Sr Regulatory Licensing Specialist {hybrid}

This role is hybrid - one day in the office per week.

Responsible for a portfolio of wholesale distributor and pharmacy across all 50 states for Patterson Companies. As part of the team your role will be to solve complex application issues, assist in regulatory research as it pertains to facility licensure. You will be assigned a book of business and will be responsible for ensuring all licenses in your book are renewed on time. You will be responsible for State and federal licensing based on your assigned book of business. You will respond to inquiries from various regulatory agencies, including, Board of Pharmacy, DEA, FDA, Department of Agriculture and other State and Federal Regulators and internal stakeholders. Experience with National Accreditation specifically NABP Certification.

Responsibilities:

• Prepare and monitor submissions of new and renewal license/registration applications (including, FDA, DEA, State Boards of Pharmacy, and NABP) in accordance with strict requirements and deadlines.
• Facilitate registration related activities, to include reporting to respective Federal, State and /or local agencies and accreditation boards as appropriate for license maintenance.
• Manage / renew NABP Drug Distributor Accreditations for all locations and work with NABP and the facilities to obtain information and set up facilities inspections as needed.
• Research State and Federal laws pertaining to laws and regulations that affect licensing compliance and advise manager as appropriate to ensure compliance with Federal, State and local licensing regulations.
• Develop and maintain professional contacts and relationships with various regulatory authorities through effective written and verbal communication as requested.
• Work within Company systems to maintain licensing data and documentation.
• Support field personnel with issue resolution involving facility and/or materials licensing/registration.
• Assist with preparation of reports and subsequent analysis for operational efficiency regulatory compliance.
• Act as a liaison between the field and Patterson Regulatory Department for licensing-related issues and contribute to applicable communication between parties as necessary.
• Ensure collaboration and ongoing communication with Customer Service, Sales, Marketing, Purchasing, Logistics, Finance and Legal.
• Function as part of a team by assisting with other duties relating to regulatory compliance in the U.S. as assigned.

Required:

• Bachelor’s degree or equivalent combination of education and experience
• 3+ years of experience in a regulatory or compliance-focused role, preferably in a healthcare or pharmaceutical setting.
• Excellent organization with the ability to track and prioritize multiple, simultaneous tasks
• Strong attention to timeliness, details and accuracy
• Ability to prioritize and follow through on tasks to completion
• Strong computer skills including MS Windows, MS Excel, and MS Outlook, with the aptitude to learn SAP
• Excellent written and verbal communication skills
• Internet proficiency
• Prior experience drafting professional correspondence
• Ability to work independently
• Strong reading and interpretation skills
• The ability to maintain a high level of confidentiality

Preferred:

• Paralegal Certificate
• Experience working with National Accreditation Boards
• Notary Designation
• Experience researching and interpreting Federal and State regulations
• Experience preparing new and renewal license/registration applications
• Experience collecting information on licensing regulations
• Working with regulators in various state or federal regulatory agencies
• Experience working with a variety of corporate team including Customer Service, Sales, Marketing, Purchasing, Logistics, Finance and Legal