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Regulatory Affairs Specialist

2 months ago


Reston, Virginia, United States Precision Point Staffing Full time

We are supporting a small growing biotech company in the life sciences industry, seeking a Senior Regulatory Affairs Associate to join our team at Precision Point Staffing


Key Responsibilities:


  • Support the development and implementation of regulatory strategies to ensure compliance with health authorities.
  • Collaborate with cross-functional teams to ensure accurate and timely submissions to regulatory agencies.
  • Provide regulatory guidance and support for pharmaceutical development, including INDs and CTAs in the US, Europe, Australia, and Asia.
  • Manage and maintain regulatory documents, including ICH and CFR guidelines.
  • Develop and maintain relationships with regulatory agencies and health authorities.
  • Stay up-to-date with regulatory changes and updates, and provide training to the team as needed.

Requirements:


  • Bachelor's Degree in a scientific or mathematical area.
  • At least 2 years of experience in a regulatory setting at a biotech company.
  • Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory matters.
  • Proficiency with Windows, Adobe, and eCTD software.