Senior Regulatory Affairs Manager

hace 5 días


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

Job Summary

Qrc Group Llc is seeking a seasoned Regulatory Consultant to provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments. The successful candidate will be responsible for providing strategic regulatory advice, developing and reviewing regulatory submissions, evaluating facility design, staying up-to-date with industry standards, and supporting CAPA plans.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with FDA and global regulatory standards.
  • Prepare and review comprehensive regulatory submissions to the FDA, ensuring accuracy and completeness.
  • Evaluate and advise on the regulatory aspects of facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.
  • Stay current 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.


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