Senior Manager, Regulatory Sciences Compliance

Role: Senior Manager, Regulatory Sciences Compliance, overseeing compliance frameworks and activities across Regulatory Strategy, Operations, Labeling, and Pharmacovigilance in a biopharma setting. Objectives: ensure GCP and GVP compliance, maintain inspection readiness, and promote continuous improvement. Responsibilities: develop and monitor compliance metrics, oversee deviations and CAPAs, support internal audits and inspections, coordinate responses to findings, and drive governance initiatives. Qualifications: Bachelor’s in Regulatory Affairs, Life Sciences, or related field; 4+ years in pharma/biotech, with strong knowledge of global regulatory requirements, pharmacovigilance, and Quality Management Systems. Preferred: experience supporting regulatory inspections, working in GxP environments, and cross-functional compliance oversight. HighValue: pharmacovigilance, regulatory compliance, inspection readiness, GxP, and QMS in a biopharma context. WorkSetup: hybrid in Cambridge, MA; no travel specified.