Supv Regulatory Affairs Licensing WFH Updated

JOB SUMMARY

Position is a WFH (work from home) opportunity. Candidate needs to be located in Chicagoland area or Southeast Wisconsin and able to commute into Northfield headquarters location when necessary.

Provide daily oversight of a team tasked with facility licensing 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.

MAJOR RESPONSIBILITIES

• Manage the state and federal regulatory licensing activities necessary to support and maintain the business, including registrations and reporting activities.
• 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.

Job Requirements:

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 regulatory compliance preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Knowledge / Skills / Abilities

• Experience preparing and filing regulatory required documents.
• Experience applying knowledge of the CFRs, FDA, BOP 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.