Regulatory Compliance Lead

About the role

The Regulatory Compliance Lead role is responsible for leading a team of professionals to ensure compliance with regulatory requirements and quality systems across all aspects of pharmaceutical manufacturing, testing, storage, and distribution. This role will also support inspection readiness, manage regulatory risk assessments, and collaborate with cross-functional teams to implement compliance plans.

Responsibilities

• 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, providing guidance to the impact on regulatory submissions, RIS (Regulatory Implementation Strategy), and assisting change owners in the assessment of scope for the change.
• Manage the implementation of 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 assure all mandatory licenses and registrations are kept current and in compliance with relevant health authority requirements.
• 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 the management of regulatory compliance and quality systems using established procedures and guidelines.
• Accountable for employee development and/or performance management through activities such as assignments and associated technical training programs.
• Coach direct reports with problem solving.
• Support Quality Compliance Director with succession planning, setting team objectives, and implementation of new departmental strategies.
• Act as single point of accountability for site regulatory compliance.
• Create an environment where strategic decision making is encouraged in order to drive site regulatory compliance for all new and existing products.
• Manage the Periodic Product Review (PPR) Program for the Site.

Requirements

• 8+ years' experience in cGMP environment, with 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).
• Must have a minimum 2 years as a people leader.
• BS or BA in relevant technical discipline, including life sciences, engineering, regulatory affairs, or a related field, or equivalent experience.
• Sufficient technical depth or professional experience will be considered in lieu of technical degree.
• Demonstrated experience with GMP's, FDA, MHRA, EMA and other regulatory agency requirements for pharmaceutical validation and operations, analytical and stability functions and compliance.
• Demonstrated experience with GMP's, 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.

Qualifications

• 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.
• Effective at implementing decisions.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.
• Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
• Good understanding and interpretation of Global regulations pertaining to the manufacture, holding, and distribution of human drug products.
• Good working knowledge of regulatory affairs, including submissions/supplements/variations and approved dossiers.
• Demonstrated experience supporting regulatory inspections and audit activities. Strong knowledge of US regulatory requirements and good manufacturing practices.
• Proven ability to lead cross-functional projects and influence stakeholders.
• Excellent written and verbal communication skills with attention to detail.
• Experience with global regulatory interactions and harmonization activities.
• Experience coaching teams and building compliance capability.
• Familiarity with quality management systems and trending tools.
• Experience writing regulatory submissions or formal responses to authorities.
• Prior experience in continuous improvement or operational excellence programs.