Manager Quality and Regulatory Compliance; Remote

Complaints Management and Regulatory Quality – fielding routine customer complaints and compliance oversight for marketed products. Need experience on quality side interacting with FDA.

• Management of Complaints: including inbox management, initial assessment, triage to CPQ, and tracking to investigations to closure (20%)
• Support development, authorship, and period reviews of US RA own compliance and product life cycle management standard operating procedures (10%)
• Support authorship of compliance communication documentation including but not limited to:
  Field Alert Reports, drug shortage communications, recalls, etc. to ensure on-time submission/completion (10%)
• Support authorship of product right to operate documentation including but not limited to Annual Reports, Safety Reports, Cover letters, Submission/Document Indices, creation of unique , completion of Forms, REMs cross reference submissions, etc and ensure on-time submission/completion (10%)
• Support review of SPL for Drug Establishment, Drug Listing, etc (5%)
• Support development and implementation of inspection readiness tools, preparation documentation, and/or training materials (10%)
• Support inspections by assisting with pre-inspection/inspection document request, assisting with identifying inspection risk, and addressing inspection risks (5%)
• Support authorship of US RA owned compliance deviations (5%)
• Support triage of product regulatory/quality assessment request to GRL, GSL, Reg Ops, RA CMC, and/or external manufacturing QA (10%)
• Support post approval supplement submissions by interacting with cross functional teams to ensure all documents are submission ready and listed in submission/document indices (10%)
• Support Mature Brand RAFT by leading meeting, scheduling meetings, preparing agendas, taking meeting minutes, tracking status of action items, etc. (5%)