Manager, Regulatory Compliance

Position Summary

This role manages site regulatory compliance processes, including reporting, licensing support, Quality Technical Agreements, and documentation such as the Site Master File and Quality Manual. The position collaborates with Quality, Operations, Regulatory Affairs, Supply Chain, and Engineering teams to support inspections, fulfill commitments, and drive continuous improvement. The Manager also leads and develops Regulatory Compliance personnel to ensure objectives are achieved in line with regulatory requirements and current Good Manufacturing Practices.

The Role

• Lead and maintain site regulatory compliance programs to ensure adherence to applicable requirements, commitments, company standards, and current Good Manufacturing Practices.
• Manage regulatory submissions, commercial data reporting, licensing activities, and maintenance of regulatory records supporting site operations.
• Own and maintain the Site Master File and Quality Manual, ensuring documents remain current, accurate, and compliant.
• Develop, review, negotiate, approve, and maintain Quality Technical Agreements with customers, suppliers, contract manufacturers, and business partners.
• Support regulatory agency, customer, and pre-approval inspections through documentation preparation, coordination of responses, and follow-up activities.
• Coordinate and track inspection observations, commitments, and corrective action plans to ensure timely completion and sustained compliance.
• Partner with Quality Systems, Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to support investigations, change controls, CAPAs, risk assessments, and compliance improvement initiatives.
• Monitor emerging regulatory requirements, industry trends, and guidance documents to assess potential impacts on site quality systems and operations.
• Lead, coach, develop, and manage Regulatory Compliance personnel, including performance management, employee development, and resource allocation.
• Perform other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• Minimum five years of experience in pharmaceutical, biotechnology, API manufacturing, quality assurance, regulatory compliance, or another regulated industry.
• Experience with regulatory submissions, site licensing activities, and regulatory reporting.
• Experience working within current Good Manufacturing Practice-regulated environments.
• Experience supporting FDA and/or international regulatory inspections.
• Minimum two years of direct people management experience, including employee coaching, performance management, and development.
• Strong knowledge of pharmaceutical regulations, current Good Manufacturing Practices, quality systems, and regulatory compliance requirements applicable to pharmaceutical and API manufacturing.
• Demonstrated expertise in regulatory submissions, reporting, licensing activities, and management of regulatory documentation, including Site Master Files and Quality Manuals.
• Strong understanding of inspection support activities, regulatory commitments, CAPAs, change controls, investigations, risk management, and continuous improvement processes.
• Excellent leadership, communication, negotiation, and influencing skills, with the ability to partner across functions and manage relationships with customers, suppliers, and regulatory stakeholders.

Preferred Skills & Background

• Experience managing Site Master Files and Quality Manuals.
• Experience with Quality Technical Agreements.