Regulatory Manager

4 weeks ago

Miami, United States CRO Strategies Full time

As the Regulatory Manager, you will be responsible for ensuring that all regulatory aspects of clinical research trials conducted at our site are managed effectively and in accordance with federal and state regulations, institutional policies, and study sponsor requirements. You will work closely with the clinical research team, Institutional Review Boards (IRBs), study sponsors, and other stakeholders to ensure compliance and promote a culture of integrity and ethical conduct.


Key Responsibilities:


Regulatory Compliance:

  • Ensure compliance with all applicable federal, state, and local regulations, including FDA, ICH-GCP, and IRB requirements.
  • Maintain up-to-date knowledge of regulatory requirements and best practices in clinical research.


Submission Management:

  • Prepare and submit study-related documents to IRBs and other regulatory bodies as required.
  • Coordinate and manage IRB submissions, including initial applications, amendments, continuing reviews, and study closures.


Study Documentation:

  • Oversee the maintenance of regulatory binders and ensure proper documentation for all studies.
  • Ensure accurate and timely filing of regulatory documents, including informed consent forms, investigator brochures, and adverse event reports.


Quality Assurance:

  • Conduct periodic internal audits to ensure regulatory compliance.
  • Identify areas for improvement and recommend corrective and preventive actions.

Training and Education:

  • Provide training and guidance to clinical research staff on regulatory requirements and best practices.
  • Develop and maintain standard operating procedures (SOPs) related to regulatory compliance.

Liaison with Stakeholders:

  • Serve as the primary point of contact with IRBs, study sponsors, and regulatory authorities.
  • Communicate regulatory requirements and updates to relevant stakeholders.

Safety Monitoring:

  • Monitor safety reports and adverse events, ensuring timely reporting to IRBs and study sponsors as required.
  • Participate in safety monitoring committees and safety reviews as needed.

Qualifications:

  • Bachelor’s degree in a related field (e.g., life sciences, healthcare, regulatory affairs).
  • Minimum of 3 years of experience in regulatory affairs, clinical research, or a related field.
  • Strong knowledge of FDA regulations, ICH-GCP guidelines, and IRB processes.
  • Excellent organizational and communication skills.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Experience with electronic regulatory systems (e.g., IRB portals, CTMS) is a plus.
  • Regulatory Affairs Certification (RAC) or other relevant certification is preferred but not required.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for career advancement and professional development.
  • Collaborative and supportive work environment.


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