Senior Regulatory Consultant

hace 2 días


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

Job Summary

The Qrc Group, Llc is seeking a seasoned Senior Regulatory Consultant to provide expert guidance and support in navigating the aseptic production environment. As a senior consultant, you will play a critical role in ensuring compliance with FDA and global regulatory standards.

Key Responsibilities:

  • Develop and implement comprehensive regulatory strategies to ensure compliance with FDA and global standards.
  • Provide expert regulatory advice for aseptic manufacturing processes, including process development and validation.
  • Lead regulatory submissions to the FDA, including product applications and facility approvals.
  • Stay up-to-date with FDA regulations and industry standards for aseptic processing.
  • Collaborate with cross-functional teams to ensure effective implementation of regulatory strategies.

Requirements:

  • Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred).
  • 10+ years of regulatory experience within the pharmaceutical or biotechnology industry.
  • Proven track record of success in regulatory affairs, including experience with aseptic manufacturing.
  • Strong leadership and project management skills.

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