Regulatory Affairs Specialist, Aseptic Production

hace 2 días


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

About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Qrc Group, Llc. As a specialist in aseptic production, you will be responsible for providing expert guidance and support in navigating the complex regulatory landscape.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with FDA and global standards.
  • Prepare and review regulatory submissions, including product applications and facility approvals.
  • Conduct risk assessments and provide recommendations for mitigating regulatory risks.
  • Maintain knowledge of 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).
  • 5+ years of regulatory experience within the pharmaceutical or biotechnology industry.
  • Proven track record of success in regulatory affairs, including experience with aseptic manufacturing.
  • Strong communication and project management skills.


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