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 regulatory compliance team ensure the team completes their assigned activities and meet established expectations.
Customer Licensing is responsible for ensuring compliance with state and federal laws and regulations for the purchase of prescription drugs, medical devices, and other regulated products.
MAJOR RESPONSIBILITIES
- Manage state and federal regulatory activities necessary to support and maintain compliance with applicable laws and regulations related to customer licensing and distribution of prescription drugs. (State Board of Pharmacy, FDA, DSCSA).
- 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. - 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.
MINIMUM JOB REQUIREMENTS
Work Experience
- At least 3 year experience in the Regulatory compliance industry.
Knowledge / Skills / Abilities
- 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 JOB REQUIREMENTS
Education
- Bachelor's 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.
Work Experience
- At least 1 year of experience in licensing or regulatory affairs preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Knowledge / Skills / Abilities
- Experience in evaluation of information to determine compliance with standards, laws, and regulations.
- Experience applying knowledge of state and federal laws and regulations related to wholesale drug distribution, DSCSA, and NABP.
- 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
