Clinical Regulatory Specialist

The Clinical Regulatory Specialist ensures compliance with regulations and standards for clinical trials and research, managing regulatory submissions, maintaining documentation, and providing regulatory guidance to research teams.



Responsibilities

• Prepare and submit regulatory documents for INDs, NDAs, MAAs to health authorities.
• Ensure compliance with regulations and guidelines, as well as those of other regulatory agencies.
• Maintain accurate and organized regulatory documentation, records, and databases.
• Provide guidance and support to research teams on regulatory matters, including protocol development, informed consent forms, and other study documents.
• Manage and maintain regulatory information
• Participate in internal and third-party audits

Requirements

• Bachelor's Degree in a life science field.
• 3 years of clinical regulatory experience

*6 month contract opportunity; full-time hours, remote working