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Senior Regulatory Affairs Study Start-Up Specialist
CTI Clinical Trial and Consulting ServicesSenior Specialist managing essential regulatory documentation for global clinical studies. Collaborating with study teams and regulatory bodies to ensure compliance and timely submissions.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing regulatory documentation and compliance assessments for clinical studies, ensuring adherence to country-specific requirements and preparing for audits and inspections.
Highest-signal resume keywords
Regulatory Documentation ManagementCompliance AssessmentIRB/EC/CA SubmissionsPharmaceutical Regulatory ExperienceClinical Study Support
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory DocumentationCompliance AssessmentClinical Study DocumentationAudit PreparationDocument Review
Soft Skills
Interpersonal CommunicationAttention to DetailProblem Solving
Industry Keywords
CROPharmaceuticalClinical ResearchRegulatory RequirementsSite Personnel Interaction
About the role
Key responsibilities & impact- Independently manage essential regulatory documentation for submission to various bodies for clinical studies
- Assist project teams on regulatory requirements
- Perform compliance assessments and notify Project Managers of findings
- Review and adapt study specific documents
- Oversee IRB/EC/CA submissions on behalf of sponsors
- Interact with site personnel for document corrections
- Compile regulatory documentation according to applicable country requirements
- Prepare for sponsor or agency audits and inspections
Requirements
What you’ll need- Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
- At least 5 years of relevant pharmaceutical, site, or CRO Regulatory experience
Benefits
Comp & perks- Health benefits
- Paid parental leave
- Tuition reimbursement
- Training courses
- Work-life balance
- Generous vacation packages