Regulatory Compliance Lead

Position Summary

This role leads a team of professionals acting as advisor, facilitator, and team member regarding regulatory compliance and pertinent quality systems for all aspects of the manufacturing, testing, storage and distribution of pharmaceutical products. It provides guidance and training to employees and assists them with decision‑making. The role leads regulatory compliance activities across US operations, working with quality, manufacturing, and technical teams to ensure compliance with regulations and company standards.

• Lead regulatory compliance programs and ensure alignment with US and global regulatory requirements.
• Support inspection readiness, including responses to regulatory authority requests and audits.
• Manage regulatory risk assessments and drive corrective and preventive actions to closure.
• Collaborate with cross‑functional teams to implement compliance plans and improve processes.
• Prepare clear reports and metrics for leadership on compliance status and improvement initiatives.
• Coach and influence colleagues to build a proactive compliance culture across the organization.
• Ensure all proposed technical changes are properly assessed via the Change Control System and provide guidance on regulatory submissions, RIS, and assessment of scope for change owners.
• Represent the site in regulatory input meetings (e.g., PTRT, CoPs, Change Control Panel).
• Manage registered commitments to ensure continuous compliance and success in global regulatory authority inspections (e.g., FDA).
• Coordinate efforts with GSK Regulatory Affairs, LOCs, and other business departments to keep all mandatory licenses and registrations current and compliant.
• Oversee the management of Quality Agreements (QA and iQA) and Quality Agreement Product Requirements Specifications (QAPRS) for API’s supplied to Zebulon, US marketed products managed by Zebulon, products supplied by Zebulon and Secondary Contract Manufacture (SCM) products managed by Zebulon.
• Supervise employees related to regulatory compliance and quality systems using established procedures and guidelines.
• Accountable for employee development and performance management through assignments and technical training programs.
• Coach direct reports with problem solving.
• Support the Quality Compliance Director with succession planning, setting team objectives, and implementation of new departmental strategies.
• Act as the single point of accountability for site regulatory compliance.
• Create an environment encouraging strategic decision‑making to drive site regulatory compliance for all new and existing products.
• Manage the Periodic Product Review (PPR) Program for the Site.

• 8+ years' experience in cGMP environment.
• 5+ years in regulatory affairs or a quality or regulatory compliance role with hands‑on regulatory compliance experience in a regulated industry (pharmaceutical, biotech, or similar).
• Minimum 2 years as a people leader.
• BS or BA in a relevant technical discipline (life sciences, engineering, regulatory affairs) or equivalent experience.
• Demonstrated experience with GMPs, FDA, MHRA, EMA and other regulatory agency requirements for pharmaceutical validation and operations, analytical and stability functions, and compliance.
• Demonstrated experience with GMPs, NIH Guidelines, FDA and other regulatory agency requirements (preferred).
• Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
• Demonstrated experience supporting regulatory inspections and audit activities.
• Strong knowledge of US regulatory requirements and good manufacturing practices.

• Advanced degree in a relevant scientific or technical discipline.
• Good written communication, organizational, and computer skills.
• Ability to prioritize and decide appropriate course of actions and effectively implement decisions.
• Experience interacting with peers, subordinates, and senior personnel in multidisciplinary environments (engineering, facility operations, validation, production, QC).
• Good understanding and interpretation of global regulations pertaining to the manufacture, holding,…