Regulatory Affairs Expert

hace 2 días


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

At Qrc Group Llc, we are seeking a Regulatory Affairs Expert to provide expert guidance and support in navigating the regulatory landscape of aseptic production environments.

The ideal candidate will possess a strong understanding of FDA regulations and aseptic processing guidelines. Key responsibilities include:

  • Providing expert regulatory advice for aseptic manufacturing processes, ensuring compliance with FDA and global regulatory standards.
  • Preparing and reviewing regulatory submissions to the FDA, ensuring timely and accurate submission of required documents.
  • Assessing and advising on the regulatory aspects of facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.
  • Staying up-to-date with FDA regulations and industry standards for aseptic processing and pharmaceutical products.
  • Supporting the preparation and submission of Corrective and Preventive Action (CAPA) plans and responses to regulatory authorities.

Required qualifications include:

  • 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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