Manager, Regulatory Compliance

Catalent Pharma Solutions•Kansas City, MO

3d•Onsite

About The Position

The Manager, Regulatory Compliance manages site regulatory compliance processes at Catalent’s Kansas City facility, including regulatory reporting, licensing support, Quality Technical Agreements, and controlled documentation such as the Site Master File and Quality Manual. The position works with Quality, Operations, Regulatory Affairs, Supply Chain, and Engineering to support inspections, fulfill regulatory commitments, and drive continuous improvement. The Manager also leads and develops Regulatory Compliance personnel to achieve objectives in line with regulatory requirements and current Good Manufacturing Practices. This is a 100% onsite position in Kansas City, Missouri, with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule.

Requirements

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
At least 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 in current Good Manufacturing Practice-regulated environments.
Experience supporting FDA and/or international regulatory inspections.
At least 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.
Expertise in regulatory submissions, reporting, licensing activities, and management of regulatory documentation, including Site Master Files and Quality Manuals.
Strong understanding of inspection support, regulatory commitments, CAPAs, change controls, investigations, risk management, and continuous improvement processes.
Excellent leadership, communication, negotiation, and influencing skills, including the ability to partner across functions and manage relationships with customers, suppliers, and regulatory stakeholders.

Nice To Haves

Experience managing Site Master Files and Quality Manuals.
Experience with Quality Technical Agreements.
Demonstrable leadership experience at Catalent, including participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW, may be considered in place of external experience.

Responsibilities

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 regulatory records that support site operations.
Own and maintain the Site Master File and Quality Manual, ensuring that 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 document preparation, response coordination, and follow-up.
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 on 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.