The primary function of this role is to ensure that regulatory obligations for products and facilities in both development and lifecycle management comply with the most current regulatory standards and that compliance risks are appropriately identified and mitigated.
Support Regulatory Affairs & Compliance oversight activities by:
— Maintaining status and oversight on Regulatory-related commitments
— Maintaining status oversight on Audit Observations & related CAPA status assigned to the RA/Compliance group
— Monitoring Regulatory/Compliance regulations and standards related to FDA expectations for pharmaceutical production, cGMP, DEA, USP-NF and Labeling for status and effectiveness o Analyzing production and product related data for trending, process analysis and product understanding
— Analyzing Audit/Inspection observations related to Regulatory/Compliance activities for trending and change control/CAPA related effectiveness.
— Support Regulatory Compliance and Quality Documentation Management:
— Coordinate creation and maintenance of Policies, Standard Operating Procedures and standards
— Support maintenance of and compliance to training plans.
Manage Regulatory-related Deviations & CAPA process for the GRA Practice:
— Manage/Support QMS process for Regulatory Affairs and Compliance, Facilitate Audit/Inspection-related activities impacting the organization
— Support Audit & Inspection-readiness activities
— Collaborate with Audit/Inspection Observations, responsible departments and related CAPA owners by providing support to facilitate timely resolution and closure.
— Provide Compliance expertise in initiatives and in projects:
— Participate in compliance/risk mitigation and process improvement initiatives in collaboration with cross-functional teams
— Build & maintain expertise, oversight & network through projects
— Share information within the organization to foster growth of Compliance in knowledge and practice
— Participate to workshops & organize meetings/trainings with stakeholders.
— BS/ MS degree in Engineering or Science with minimum 8 years of relevant experience in the pharmaceutical industry, with a minimum of 4 years in Regulatory Affairs, Compliance and/or and Quality Assurance within the Pharmaceutical industry.
— Regulatory audits and inspections experience is required. Experience working in a cGMP/manufacturing environment is required.
— Regulatory submissions writing/review experience is strongly preferred.
— Knowledge and understanding of Regulatory Affairs and Compliance Processes, Quality Assurance, Quality Management System, Artwork management, Supply Chain, Understanding of Generic Pharmaceutical Business.
Job Functions: Regulatory Affairs / Regulatory Compliance
Salary: $85,000.00 – $95,000.00Apply / Submit Resume