Regulatory Compliance Lead
Core
Lead regulatory compliance programs and ensure alignment with US and global regulatory requirements for pharmaceutical manufacturing, testing, storage, and distribution.
Role type
Senior IC Regulatory Compliance Lead
Builds
Compliance programs, inspection readiness, and corrective/preventive actions for pharmaceutical products
Domain
Pharmaceutical manufacturing and regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP environment experience, regulatory affairs leadership, FDA/MHRA/EMA compliance, change control system management, Quality Agreements oversight, team coaching, periodic product review management
Preferred skills
Advanced degree in life sciences, global regulatory harmonization, regulatory submissions experience, continuous improvement programs, stakeholder influence
Technologies
Change Control System, Quality Agreement Product Requirements Specifications (QAPRS), Periodic Product Review (PPR) Program
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
Seniority
Senior, hands-on IC with people leadership
