Regulatory Start-Up Specialist II: Submissions & Ethics

Novotech; South Dakota; On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Wellness programs

Job summary

A leading clinical research organization is seeking a Regulatory Start Up Associate in South Dakota. The role involves planning, preparation, and review of regulatory authority applications during project start-up to ensure timely clinical trial approvals. Candidates must have a degree in clinical or life sciences and relevant experience. This position offers flexible working options and a supportive work environment.

Qualifications

• 1-2 years of related experience in CRO, pharmaceutical or clinical/hospital environment.
• Responsible for quality start-up deliverables at country and site level.
• Knowledge of ICH-GCP and local regulatory requirements.

Responsibilities

• Serve as primary contact for RSM and/or PM during start-up on allocated projects.
• Prepare and submit Central EC/IRB applications and local EC/Governance applications.
• Ensure submission packages are accurate and complete per local requirements.

Skills

Regulatory knowledge

Project management

Attention to detail

Education

Graduate in clinical, pharmacy or life sciences

Job description

A leading clinical research organization is seeking a Regulatory Start Up Associate in South Dakota. The role involves planning, preparation, and review of regulatory authority applications during project start-up to ensure timely clinical trial approvals. Candidates must have a degree in clinical or life sciences and relevant experience. This position offers flexible working options and a supportive work environment.