• The Regulatory Compliance Manager is responsible for maintaining status and oversight on Regulatory related commitments.
• Maintaining status oversight on Audit Observations & related CAPA status.
• Monitoring Regulatory / Compliance regulations and standards related to FDA expectations for pharmaceutical production, cGMP, DEA, USP-NF and Labeling for status and effectiveness.
• Analyzing production and product related data for trending, process analysis and product understanding.
• Relocation provided.
• The Regulatory Compliance Manager will have a BS or MS degree and 8+ years of relevant experience in the pharmaceutical industry.
• 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.
• Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.