Regulatory Consultant

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.
Requisitos:
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.