Regulatory Operations Coordinator Job at Cencora

Job Description

This role is in support of Cencora's veterinary and livestock production solutions marketed through our MWI Animal Health business. MWI Animal Health is a leading brand of Cencora, offering animal health services globally. The Regulatory Coordinator plays a crucial role in ensuring compliance with MWI policies and procedures. Primary responsibilities include supporting quality-related activities for our premium brand product portfolio.

Job Responsibility

Organize and support management review meetings in accordance with applicable SOPs
Work closely with subject matter experts to ensure suppliers meet quality expectations through audits, performance monitoring, and corrective actions when necessary
Negotiate and maintain quality agreements with suppliers and manufacturers for MWI’s premium brands
Respond promptly to audit inspection inquiries by providing accurate information and supporting documentation
Work with the management teams to develop follow-up action plans for addressing any identified non-compliance issues
Review and manage the documentation on adverse events and quality complaint incidents
Provide quality input for investigations and support corrective and preventive action initiatives to address root causes
Organize regular reviews Standard Operating Procedures (SOPs) and Work Instructions (WIs) with process owners to these documents align with established service standards as well as quality and regulatory requirements
Verify adherence of MWI employees to all company policies and procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation
Ensure that MWI License(s) as well as any other regulatory documentation is up to date
Identify opportunities for process improvements through data analysis and continuous evaluation of existing workflows
Perform other duties as assigned

Requirements

Bachelor's degree preferred, in healthcare or science discipline or 2 years of professional experience in a healthcare setting or pharmaceutical company
Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance
Experience in auditing, risk management, and/or quality management
Knowledge of QMS software preferred
Excellent oral and written communication skills
Ability to effectively manage and participate in cross-functional problem-solving teams
Excellent teamwork and people skills
Ability to handle a variety of tasks simultaneously
Excellent critical thinking skills to evaluate quality problems and apply knowledge to identify appropriate solutions

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families which may include backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions
paid parental leave
paid caregiver leave
variety of training programs
professional development resources
opportunities to participate in mentorship programs
employee resource groups
volunteer activities

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