About the position Our Regulatory Affairs Specialist II primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines. The Regulatory Affairs Specialist I will maintain a full study workload with minimal supervision. This position is a US-based remote position; relocation assistance and work sponsorship are not available.

Responsibilities

• Establishes and maintains a document management system for regulatory electronic files
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
• Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content
• Maintains critical documentation ensuring compliance
• Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA. This includes time sensitive correspondence with sponsors and other stakeholders.
• Organizes and processes documentation for IRB submission for multiple trials
• Processing of Protocol Deviations that meet the IRB reportable criteria
• Submits urgent safety notifications to the IRB
• Other duties as assigned

Requirements

• high school graduation diploma required - qualified experience may be substituted for education
• 3+ years' regulatory affairs work experience in a clinical research, pharmaceutical, site management organization highly desired
• Knowledge of medical terminology, FDA, other regulatory processes highly preferred

Nice-to-haves

• Associate's Degree or higher is preferred

Benefits

• competitive compensation package
• annual bonus or long-term incentive opportunities may be offered