Regulatory Affairs Specialist
Job Summary
Managing essential regulatory documentation for clinical studies, the full-time remote Regulatory Affairs Specialist will assist project teams with compliance assessments, perform IRB/EC submissions, and maintain documentation throughout the trial lifecycle.
Key responsibilities
- Assist and advise project teams on regulatory requirements for clinical studies
- Perform compliance assessments and document findings, notifying project managers as necessary
- Compile and review regulatory documentation, ensuring quality and completeness before submission
Required qualifications
- Associate's or Bachelor's degree in an allied health field such as nursing, pharmacy, or health science
- A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO regulatory experience
- Experience with IRB/EC submissions and regulatory documentation processes
- Familiarity with local country requirements for clinical studies
- Ability to interact effectively with sponsors and site personnel
Complete Job Description
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