Responsibilities
- 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.
Requirements
- 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.