Regulatory Project Specialist

hace 2 días


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

We are looking for a Regulatory Project Specialist to lead and manage projects in the aseptic areas. The successful candidate will be responsible for coordinating and overseeing all stages of project execution from design, development, and validation through to FDA submission.

The ideal candidate will have a strong understanding of FDA regulations, aseptic processing, and good manufacturing practices. They will also possess excellent communication and interpersonal skills, as well as the ability to work effectively in a team environment.

  • Manage risk assessments and mitigation strategies.
  • Conduct periodic project reviews and provide status reports to senior management.
  • Possess PMP certification or equivalent experience.

This role requires a Master's degree in a relevant field and 8+ years of experience in project management in a regulated industry.



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