Senior Manager, Regulatory Sciences Compliance
Core
Develop and maintain the Regulatory Sciences compliance framework and provide oversight of compliance activities across Regulatory Strategy, Regulatory Operations, Labeling, Global Safety Operations, Medical Safety, and Risk Management functions.
Role type
Senior Manager, Regulatory Sciences Compliance
Builds
Sustainable inspection readiness and compliance alignment for Regulatory Sciences subfunctions
Domain
Life Sciences / Regulatory Affairs / Quality Management
Deliverable
dashboards & analysis
Required skills
Regulatory compliance framework design, GxP knowledge (GCP, GVP), risk management, governance, deviation/CAPA management, audit coordination, KPI definition and monitoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Support and augment the QSC compliance framework for Regulatory Sciences activities; Provide compliance governance across relevant Regulatory Sciences subfunctions; Identify compliance risks and implement mitigation strategies; Partner with stakeholders to define, maintain, and monitor KPIs and compliance metrics; Develop and maintain compliance reports and dashboards; Analyze compliance trends and identify systemic issues; Support oversight and management of deviations, CAPAs, and quality issues; Support internal audits and regulatory inspections impacting Regulatory Sciences activities
Seniority
Senior Manager, hands-on leadership
