Manager, Regulatory Compliance

About Site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary We have an opportunity for a Manager, Regulatory Compliance to join our team. 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.

Shift: M-F 8am-5pm Location: Kansas City, MO 100% Onsite

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.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Preferred Skills & Background

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

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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