Senior Manager, Regulatory Sciences Compliance

Role: Senior Manager, Regulatory Sciences Compliance, overseeing compliance frameworks and activities across Regulatory Strategy, Operations, Labeling, and Safety functions in biopharma. Objectives include ensuring adherence to GCP and GVP standards, supporting inspection readiness, and fostering continuous improvement. Responsibilities encompass developing compliance metrics, managing deviations and CAPAs, supporting audits and inspections, and driving governance initiatives. Requirements: Bachelor's in Regulatory Affairs, Life Sciences, Pharmacy or related; 4+ years in pharma/biotech industry, with strong knowledge of global regulatory and quality systems, and experience supporting regulatory inspections. Preferred: advanced degree, experience in pharmacovigilance compliance, and working within a Quality Management System. High-value details include focus on pharmacovigilance, GxP compliance, and inspection readiness within a biotech context. Location: hybrid in Cambridge, MA; no travel specified.