Regulatory Compliance Lead
GSK
August 21, 2026
Remote friendly (Zebulon, NC)
United States
Corporate Functions
Position Summary:
This role leads a team providing advisory, facilitation, and team support on regulatory compliance and quality systems across manufacturing, testing, storage, and distribution of pharmaceutical products. Leads regulatory compliance activities across US operations, providing guidance and training to employees.
Responsibilities:
- Lead regulatory compliance programs aligned with US and global regulatory requirements.
- Support inspection readiness (responses to regulatory authority requests and audits).
- Manage regulatory risk assessments and drive corrective and preventive actions to closure.
- Collaborate cross-functionally to implement compliance plans and improve processes.
- Prepare compliance status reports and metrics for leadership.
- Coach and influence colleagues to build a proactive compliance culture.
- Ensure technical changes are assessed via Change Control System, including impact on regulatory submissions and RIS.
- Ensure site representation in regulatory input meetings (PTRT, CoPs, Change Control Panel).
- Manage implementation of registered commitments (e.g., FDA) to ensure continuous compliance.
- Coordinate with Regulatory Affairs, LOCs, and business departments to keep licenses/registrations current.
- Oversee Quality Agreements (QA/iQA) and QAPRS for relevant API and product categories.
- Supervise employees managing regulatory compliance and quality systems.
- Accountable for employee development/performance and technical training; coach direct reports.
- Support Quality Compliance Director with succession planning, objectives, and strategy.
- Act as single point of accountability for site regulatory compliance; encourage strategic decision-making.
- Manage the Periodic Product Review (PPR) Program for the Site.
Basic Qualifications:
- 8+ years in cGMP environment; 5+ years in regulatory affairs/quality/regulatory compliance with hands-on compliance experience in regulated industry.
- Minimum 2 years as a people leader.
- BS/BA in relevant technical discipline (life sciences, engineering, regulatory affairs) or equivalent experience.
- Demonstrated experience with GMPs and FDA/MHRA/EMA (validation and operations, analytical and stability, compliance).
- Demonstrated experience supporting regulatory inspections/audits; strong US regulatory and GMP knowledge.
Preferred Qualifications:
- Advanced degree.
- Strong written communication, organization, computer skills; ability to prioritize and decide.
- Experience interacting across multidisciplinary teams.
- Understanding of global regulations for manufacture, holding, and distribution of human drug products.
- Regulatory affairs knowledge (submissions/variations, dossiers) and writing regulatory responses.
- Experience leading cross-functional projects; coaching/building compliance capability.
Application Instructions:
Apply and share a concise summary of how your background matches Basic Qualifications and a short example of a compliance challenge you led.
This role leads a team providing advisory, facilitation, and team support on regulatory compliance and quality systems across manufacturing, testing, storage, and distribution of pharmaceutical products. Leads regulatory compliance activities across US operations, providing guidance and training to employees.
Responsibilities:
- Lead regulatory compliance programs aligned with US and global regulatory requirements.
- Support inspection readiness (responses to regulatory authority requests and audits).
- Manage regulatory risk assessments and drive corrective and preventive actions to closure.
- Collaborate cross-functionally to implement compliance plans and improve processes.
- Prepare compliance status reports and metrics for leadership.
- Coach and influence colleagues to build a proactive compliance culture.
- Ensure technical changes are assessed via Change Control System, including impact on regulatory submissions and RIS.
- Ensure site representation in regulatory input meetings (PTRT, CoPs, Change Control Panel).
- Manage implementation of registered commitments (e.g., FDA) to ensure continuous compliance.
- Coordinate with Regulatory Affairs, LOCs, and business departments to keep licenses/registrations current.
- Oversee Quality Agreements (QA/iQA) and QAPRS for relevant API and product categories.
- Supervise employees managing regulatory compliance and quality systems.
- Accountable for employee development/performance and technical training; coach direct reports.
- Support Quality Compliance Director with succession planning, objectives, and strategy.
- Act as single point of accountability for site regulatory compliance; encourage strategic decision-making.
- Manage the Periodic Product Review (PPR) Program for the Site.
Basic Qualifications:
- 8+ years in cGMP environment; 5+ years in regulatory affairs/quality/regulatory compliance with hands-on compliance experience in regulated industry.
- Minimum 2 years as a people leader.
- BS/BA in relevant technical discipline (life sciences, engineering, regulatory affairs) or equivalent experience.
- Demonstrated experience with GMPs and FDA/MHRA/EMA (validation and operations, analytical and stability, compliance).
- Demonstrated experience supporting regulatory inspections/audits; strong US regulatory and GMP knowledge.
Preferred Qualifications:
- Advanced degree.
- Strong written communication, organization, computer skills; ability to prioritize and decide.
- Experience interacting across multidisciplinary teams.
- Understanding of global regulations for manufacture, holding, and distribution of human drug products.
- Regulatory affairs knowledge (submissions/variations, dossiers) and writing regulatory responses.
- Experience leading cross-functional projects; coaching/building compliance capability.
Application Instructions:
Apply and share a concise summary of how your background matches Basic Qualifications and a short example of a compliance challenge you led.