Regulatory Affairs Specialist

2 days ago

Glendale, California, United States Medix™ Full time
Regulatory Coordinator Job Description

Medix™ is seeking a highly organized and experienced Regulatory Coordinator to manage the submission of regulatory documents to central IRBs. This pivotal role will play a critical part in the operational efficiency of regulatory processes while contributing to a smooth transition into a fully electronic regulatory system.

Key Responsibilities:

  • Prepare and submit all necessary regulatory documents to central IRBs for study initiation and maintenance.
  • Ensure compliance with regulatory requirements, maintaining accurate and up-to-date regulatory documentation.
  • Collaborate with internal teams to bring together and organize multiple regulatory binders in preparation for the implementation of the new eReg system.
  • Support and guide the transition to eFlorence and become proficient in using the electronic signature systems.
  • Manage regulatory processes for multiple studies simultaneously.
  • Maintain a high level of organization in a rapidly evolving environment with minimal structure during the transition period.

Must-Have Skills/Qualifications:

  • Education/Experience:
  • 2-3 years of regulatory experience with a Bachelor's degree, or 3-4 years without.
  • Central IRB Expertise: Extensive experience in submitting regulatory documents to central IRBs.
  • Multi-Study Management: Proven ability to balance 15-20 studies at a time.
  • eReg System Experience: Familiarity with any electronic regulatory system.
  • Adaptability: Comfortable working in a dynamic, less structured environment during the system transition.

Nice-to-Have Skills/Qualifications:

  • Experience in regulatory affairs for Oncology clinical trials.
  • Familiarity with Phase I vaccine trials involving multiple investigators.
  • Hands-on experience with eFlorence.
  • Background in drafting amendments, though not required, this experience would be highly valuable.

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