Regulatory Affairs Study Start Up Specialist II (RASSU)

Regulatory Affairs Study Start Up Specialist II (RASSU)

Join to apply for the Regulatory Affairs Study Start Up Specialist II (RASSU) role at CTI Clinical Trial and Consulting Services

Submission Management

• Prepare, review, and manage regulatory submissions under CTR using CTIS.
• Handle regulatory submissions for medical devices, GMOs, and local country requirements in countries where CTIS is not mandated, including ethics committee submissions.
• Prepare and QC Clinical Trial Application forms (via CTIS or other national applicable systems), where applicable.
• Perform EC / CA and / or other Regulatory Bodies submissions on behalf of sponsors and / or sites in accordance with each country’s requirements.
• Respond to Deficiency Letters from EC / CA and / or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response according to country and site requirements.
• Compile and assess the accuracy and completeness of the regulatory document approval package for drug release (Regulatory Document Study Start Up Checklist).

Document Preparation and Review

Site and Team Interaction

Documentation Management and Compliance

Audit and Inspection Support

Qualifications

About CTI

Important Note

In light of recent increase in hiring scams, if you’re selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( or from our verified LinkedIn page.

Please Note

Seniority level : Mid‑Senior level

Employment type : Full‑time

Job function : Legal

Industries : Research Services

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