Supervisor Regulatory Affairs - R2401173

at Medline Industries, Inc. in Northfield, Illinois, United States

Job Description

Job Summary

Provide daily oversight of a team tasked with regulatory compliance activities. The Regulatory Affairs Supervisor will be responsible for training, planning, assigning, and directing the work of the RA Licensing Team to ensure the team completes their assigned activities and meets established expectations. The RA licensing team manages applications and renewals for wholesale drug distributor, medical device, and other state licenses for Medline distribution centers.

Job Description

Responsibilities:

• Manage new applications, renewals, tracking, and other notifications for wholesale drug, third party logistics, designated representative, pharmacy, food, and other state regulatory licenses.
• Ensure regulatory compliance with applicable regulations (State Board of Pharmacy, FDA, DSCSA) pertaining to the distribution of prescription drugs, medical devices, food, and other regulated products.
• Provide strategic insight and technical advice to successfully develop/maintain business.
• Participate/lead on cross-functional teams to ensure continuous compliance of products.
• Ensure maintenance of regulatory database tracking systems.
• Develop or maintain relevant procedures or SOP's, updating as needed and training when required.
• Foster a sense of teamwork, unity, and empower employees to take responsibility for their jobs and goals.
• Management responsibilities include:
• -Responsible for the day-to-day activities and outcomes of a group of employees.
• -Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
• Provide regulatory support and service to team members and external customers, as needed.

Qualifications:

• At least 3 year experience in the Regulatory compliance industry.
• Experience applying an understanding of the current Regulatory environment and demonstrating the ability to perform within.
• Experience evaluating information to determine compliance with standards, laws, and regulations.
• Advanced skill level in SAP or other Enterprise Resource Planning (ERP) systems.
• Advanced skill level in Excel, Word.

Preferred Qualifications:

• Bachelors Degree in a scientific discipline AND at least 2 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area. OR High school diploma or equivalent AND at least 4 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area.
• At least 1 year of experience in regulatory chemical compliance preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Experience preparing and filing regulatory required documents.
• Experience applying knowledge of the CFRs, FDA, EPA, CPSC guidelines. - Experience managing compliance activities
• Able to hold yourself and others accountable in order to achieve goals and meet commitments.
• Able to focus on continuous improvement, knowing the most effective and efficient processes.

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity