Apex Life Sciences is seeking a Regulatory Affairs Specialist III for a global pharmaceutical clients in the St Louis area!
This role is permanent and does offer relocation assistance!
The Regulatory Affairs Specialist III ensures compliance with FDA, EMA and other cGMP regulations, including client requirements. This individual is responsible for site inspection readiness, conducting internal audits of Quality systems and facilitation of client audits.
- Implementation of site inspection readiness program and regulatory inspections.
- Lead internal audits, including planning, execution, report writing, response approval and follow through of remediation activities.
- Facilitate all aspects of client audits, including planning, preparation, hosting, response development, and closeout activities.
- Provide guidance to site concerning current regulations that apply directly or indirectly to approved drug products.
- Offer knowledge of current cGMP requirements and trends to ensure that the appropriate technical support on all quality/compliance related matters is provided.
- Minimum of a Bachelor’s degree in a scientific discipline (Life Sciences, Biotechnology, or equivalent) is required.
- Minimum of 5 years of experience in a Quality role in a cGMP environment required
- Experience in conducting internal audits of Quality Systems required.
- Comprehensive knowledge of FDA/EMA regulatory requirements required.
- Ability to host client audits and regulatory inspections.
Job Type: Full-time
- GMP Quality: 5 years (Required)