Aseptic Process Specialist with Regulatory Focus

hace 3 días


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

We are looking for an accomplished Regulatory Consultant to lead our team in ensuring regulatory compliance for aseptic manufacturing operations at Qrc Group, Llc.

Key Responsibilities:

  • Develop and maintain expertise in FDA regulations and industry standards for aseptic processing and pharmaceutical products.
  • Analyze and improve regulatory processes and procedures to ensure compliance with FDA guidelines.
  • Collaborate with cross-functional teams to prepare and submit regulatory submissions to the FDA.
  • Conduct training and education programs to promote regulatory awareness and compliance across the organization.

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 track record of ensuring regulatory compliance and maintaining strong relationships with regulatory authorities.


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