Clinical Regulatory Specialist Jobs in Florida

5-10 years of clinical trial regulatory management experience.

Quality Management System/Regulatory Compliance Program

5 Years minimum regulatory experience in clinical trials

Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations

Experience gained from multiple perspectives: industry sponsor, CRO, academic, government or site level

Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research

Complete all other duties as assigned by management.

Strong interpersonal and communications skills and organizational and planning abilities needed to handle multiple tasks concurrently.

Research of International, Federal, State, local, and internal regulatory requirements

Maintain working knowledge and understanding of existing and emerging food and dietary supplement regulations.

Assisting with obtaining, and/or renewing relevant national certifications.

Work closely with the Quality Manager and Product Development teams to ensure compliance.

Ensures the Quality Management System (QMS) is up to date per regulatory and sponsor requirements and maintains assessment/audit processes and documentation

Quality Management System/Regulatory Compliance Program

Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations

Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research

Develops and maintains departmental and study level SOPs in relation to clinical trials and according to FDA regulations and GCP guidance

Coordinates review, approval, and dissemination of policies with the internal compliance committee