Regulatory Compliance Lead
GSK
August 29, 2026
Remote friendly (Zebulon, NC)
United States
Corporate Functions
Position Summary
Leads regulatory compliance and quality systems for manufacturing, testing, storage, and distribution of pharmaceutical products across US operations. Provides guidance/training to employees and partners with quality, manufacturing, and technical teams to ensure regulatory and company compliance.
Responsibilities
- Lead US/global regulatory compliance programs; ensure alignment to regulatory requirements.
- Support inspection readiness (responses to authority requests and audits).
- Manage regulatory risk assessments; drive CAPA/corrective and preventive actions to closure.
- Implement compliance plans with cross-functional teams; improve processes.
- Prepare leadership reports/metrics on compliance status and improvements.
- Coach/influence to build a proactive compliance culture.
- Assess technical changes via Change Control; advise on regulatory submission/RIS impact.
- Serve as site regulatory input representative in key meetings.
- Ensure registered commitments are implemented for successful regulatory inspections.
- Coordinate to keep licenses/registrations current and compliant.
- Oversee Quality Agreements (QA/iQA) and QAPRS for relevant product categories.
- Supervise regulatory compliance/quality systems staff; manage development/performance.
- Support Quality Compliance Director with objectives and succession planning.
- Act as single point of accountability for site regulatory compliance and manage Periodic Product Review (PPR) Program.
Basic Qualifications (Required)
- 8+ years in cGMP; 5+ years in regulatory affairs or quality/regulatory compliance; at least 2 years as a people leader.
- BS/BA in relevant technical field (or equivalent experience).
- Demonstrated experience with GMPs and FDA/MHRA/EMA and other agency requirements (validation, operations, analytical/stability).
- Strong knowledge of US regulatory requirements and GMP; experience supporting inspections/audits.
- Extensive knowledge of GSK marketed products with emphasis on CMC.
Preferred Qualifications
- Advanced degree; global regulatory interactions/harmonization.
- Experience with regulatory submissions/responses, quality management/trending tools.
- Proven cross-functional leadership and stakeholder influence; team coaching.
- Experience with continuous improvement/operational excellence.
Work Arrangement
Hybrid; expected on-site regularly with flexibility for remote work as agreed.
Application Instructions
Apply with a concise summary matching basic qualifications and a brief example of a compliance challenge you led.
Leads regulatory compliance and quality systems for manufacturing, testing, storage, and distribution of pharmaceutical products across US operations. Provides guidance/training to employees and partners with quality, manufacturing, and technical teams to ensure regulatory and company compliance.
Responsibilities
- Lead US/global regulatory compliance programs; ensure alignment to regulatory requirements.
- Support inspection readiness (responses to authority requests and audits).
- Manage regulatory risk assessments; drive CAPA/corrective and preventive actions to closure.
- Implement compliance plans with cross-functional teams; improve processes.
- Prepare leadership reports/metrics on compliance status and improvements.
- Coach/influence to build a proactive compliance culture.
- Assess technical changes via Change Control; advise on regulatory submission/RIS impact.
- Serve as site regulatory input representative in key meetings.
- Ensure registered commitments are implemented for successful regulatory inspections.
- Coordinate to keep licenses/registrations current and compliant.
- Oversee Quality Agreements (QA/iQA) and QAPRS for relevant product categories.
- Supervise regulatory compliance/quality systems staff; manage development/performance.
- Support Quality Compliance Director with objectives and succession planning.
- Act as single point of accountability for site regulatory compliance and manage Periodic Product Review (PPR) Program.
Basic Qualifications (Required)
- 8+ years in cGMP; 5+ years in regulatory affairs or quality/regulatory compliance; at least 2 years as a people leader.
- BS/BA in relevant technical field (or equivalent experience).
- Demonstrated experience with GMPs and FDA/MHRA/EMA and other agency requirements (validation, operations, analytical/stability).
- Strong knowledge of US regulatory requirements and GMP; experience supporting inspections/audits.
- Extensive knowledge of GSK marketed products with emphasis on CMC.
Preferred Qualifications
- Advanced degree; global regulatory interactions/harmonization.
- Experience with regulatory submissions/responses, quality management/trending tools.
- Proven cross-functional leadership and stakeholder influence; team coaching.
- Experience with continuous improvement/operational excellence.
Work Arrangement
Hybrid; expected on-site regularly with flexibility for remote work as agreed.
Application Instructions
Apply with a concise summary matching basic qualifications and a brief example of a compliance challenge you led.