Regulatory Specialist Jobs

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The Clinical Research Regulatory Specialist supports clinical research activities through the development of regulatory policies and protocol-specific documents including all reports for research activities from initial submission through study closure.

• The primary focus for this position is on the development, submission, maintenance, filing, and reporting of regulatory documents to achieve and maintain compliance with all internal, external, and federal policies and regulations pertaining to research involving human subjects.

Requirements:

• FDA-regulated industry experience
• Years of regulatory specialist experience in a clinical trial environment (ie premarket)
• One or more of the Regulatory Certifications- AAAHRP, SOCRA, PRIM&R and similar organizations. GCP training and/or certification