QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Regulatory Consultant will provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.

Responsibilities: 

• Provide expert regulatory advice for aseptic manufacturing processes, ensuring compliance with FDA and global regulatory standards.
• Prepare and review regulatory submissions to the FDA, ensuring timely and accurate submission of required documents.
• Assess and advise on the regulatory aspects of facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.
• Stay up-to-date with FDA regulations and industry standards for aseptic processing and pharmaceutical products.
• Support the preparation and submission of Corrective and Preventive Action (CAPA) plans and responses to regulatory authorities.

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master’s preferred).
• 5+ years of regulatory experience within the pharmaceutical or biotechnology industry, with a focus on aseptic manufacturing and FDA product submissions.
• Strong understanding of FDA regulations and aseptic processing guidelines.
• Experience in preparing for and supporting FDA inspections and audits.

All your information will be kept confidential according to EEO guidelines.