Description
The Clinical Trial Regulatory Specialist supports project teams with country- and site-specific regulatory requirements for clinical studies. Responsibilities include compliance assessments, regulatory submissions, document quality reviews, informed-consent and clinical-trial-application preparation, deficiency-letter responses, regulatory-package compilation, audit and inspection support, document archiving, and translation. The role requires an associate’s or bachelor’s degree in an allied-health field or equivalent relevant experience, plus 3–5 years of pharmaceutical, site, or CRO regulatory experience.
