Regulatory Compliance Specialist in Pharmaceutical Environment

hace 4 días


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

Qrc Group, Llc is seeking an experienced Regulatory Consultant to join our team as a subject matter expert in aseptic manufacturing regulations.

Key Responsibilities:

  • Develop and maintain deep knowledge of FDA regulations and industry standards for aseptic processing and pharmaceutical products.
  • Collaborate with cross-functional teams to prepare and submit regulatory submissions to the FDA, ensuring compliance with FDA guidelines.
  • Conduct risk assessments and develop strategies to mitigate potential regulatory risks.
  • Lead the development and implementation of quality management systems to ensure regulatory compliance.

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.
  • Proven leadership skills and ability to influence stakeholders to achieve regulatory compliance.


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