- Ensure Compliance with 21 CFR 210/211 CGMP regulations, and quality assurance standards in pharmaceutical manufacturing
- Conduct review and approval of SOPs, protocols, and validation reports.
- Manage deviations, CAPAs, and change control processes.
- Coordinate regulatory submissions such as ANDAs and maintain compliance with FDA guidelines.
- Provide training on CGMP and regulatory requirements for cross-functional teams.
- Support regulatory strategy planning throughout the product lifecycle to ensure timely market approvals and lifecycle maintenance.
- Maintain current knowledge of evolving global regulatory requirements, including EMA, ICH, and FDA guidelines.
- Assist in label development and regulatory review of packaging components to ensure compliance with FDA/ICH guidelines.
- Create and manage structured product labeling (SPL) and drug listing in FDA’s electronic submission gateway (ESG).
- Conduct review and approval of SOPs, protocols, and validation reports.
Job Type: Full-time
Pay: $25.00 - $35.00 per hour
Benefits:
- 401(k)
- Health insurance
- Paid time off
Schedule:
- Monday to Friday
Work Location: In person