Manager Quality and Regulatory Compliance (Remote)

Planet Pharma; Illinois; Hybrid; USD 85,000 - 120,000; Full time

Job summary

Planet Pharma in United States (Illinois) is seeking a knowledgeable Complaints Management and Regulatory Quality specialist to field routine customer complaints and oversee compliance for marketed products, with experience interacting with the FDA.

You will support development of US RA SOPs, compile Field Alert Reports, recalls communications, and assist with inspections and submission readiness across cross-functional teams.

Responsibilities

• 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 ID numbers, 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%)

Job description

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 ID numbers, 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%)