Regulatory Compliance Lead

Business Introduction We manufacture and supply reliable, high‑quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024. 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. You will provide guidance and training to new and existing employees and assist them with decision making. 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 and using this information to assist change owners in the assessment of scope for the change. Ensure site representation in meetings requiring regulatory input and updates (e.g., PTRT, CoPs, Change Control Panel). 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 compliant. Oversee the management of Quality Agreements (QA and iQA) and Quality Agreement Product Requirements Specifications (QAPRS) for API’s supplied to Zebulon and SCM products. Supervise employees related to the management of regulatory compliance and quality systems using established procedures and guidelines. Accountable for employee development and performance management through assignments and related 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 and drive site regulatory compliance for all new and existing products. Manage the Periodic Product Review (PPR) Program for the Site. Basic Qualifications 8+ years’ experience in a cGMP environment, with 5+ years in regulatory affairs or a quality/regulatory compliance role, and a minimum of 2 years as a people leader. BS or BA in a relevant technical discipline (life sciences, engineering, regulatory affairs, or related field) or equivalent experience. Demonstrated experience with GMP, FDA, MHRA, EMA and other regulatory agency requirements for pharmaceutical validation and operations, analytical and stability functions. Experience supporting regulatory inspections and audit activities; strong knowledge of US regulatory requirements and good manufacturing practices. Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC). Preferred Qualifications Advanced degree in a relevant scientific or technical discipline. Good written communication, organizational and computer skills; able to prioritize and decide appropriate course of actions, and implement decisions. Ability to interact with peers, subordinates and senior personnel in multidisciplinary environments. 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. 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. Work Arrangement This role is hybrid. You will be expected to work onsite regularly, with flexibility for remote work as agreed with your manager. What you can expect from us We support learning and career development and foster inclusion, clear communication, and practical action. We welcome different perspectives and want people who will help us do the right thing for patients, safely and reliably. Equal Employment Opportunity Statement GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr NCBiotech