Regulatory Compliance Specialist
hace 1 día
**Job Overview**
Qrc Group, Llc seeks a seasoned Regulatory Consultant to provide expert guidance and support in navigating the regulatory landscape for aseptic production environments. This role is critical to ensuring compliance with FDA and global regulatory standards.
**Key Responsibilities:**
- Provide expert regulatory advice for aseptic manufacturing processes, guaranteeing adherence to FDA and international regulatory requirements.
- Prepare and review regulatory submissions to the FDA, ensuring timely and accurate submission of required documents.
- Evaluate 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.
**Requirements:**
- 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.
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