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About the Role

CTI is seeking a Regulatory Affairs professional to support clinical study teams by ensuring compliance with all regulatory requirements. This role involves managing regulatory documentation, submissions, and interactions with regulatory bodies and sites.

Responsibilities

• Assist and advise project teams on regulatory requirements for clinical studies.
• Perform compliance assessments and document findings.
• Review and adapt study documents for country and site-specific requirements.
• Perform IRB/EC (CA) and other Regulatory Body submissions.
• Receive, process, and review study documentation from sites for completeness and quality.
• Interact with site personnel and project managers to resolve documentation issues.
• Compile and QC regulatory documentation according to SOPs and country requirements.
• Assist with adapting Informed Consent Forms (ICFs) per IRB/IEC requests.
• Prepare and QC Clinical Trial Application forms.
• Interact with Sponsors to forward regulatory documentation.
• Respond to Deficiency Letters from regulatory bodies in liaison with sponsors.
• Compile and assess the completeness of the Regulatory-Package for drug release.
• Provide project teams with periodic status reports and attend meetings.
• Apply naming conventions and process study documentation in TMF systems.
• Perform review, reconciliation, close-out, and archiving of study documentation.
• Assist with preparation for Sponsor or Agency audits and inspections.
• Perform QC and QA of study-related regulatory documents and reports.
• Oversee translation of regulatory documents.
• Attend study meetings and provide regulatory status reports.
• Manage site budgets and contracts depending on countries/regions.

Requirements

• Fully eligible to work in Australia.
• Associate’s or Bachelor’s Degree in an allied health field (nursing, pharmacy, health science) or equivalent relevant experience.
• Minimum of 3-5 years of relevant pharmaceutical, site, or CRO Regulatory experience.
• Ongoing willingness to learn.
• Detail-oriented.
• Ability to collaborate well in an international team environment.
• Excellent verbal and written communication skills.
• Fluent in oral and written English.
• Ability to develop, prioritize, organize, and manage multiple tasks.
• Decision-making and creative problem-solving skills.
• Working knowledge and understanding of applicable country regulations, ICH/GCP regulations and guidelines.

Skills

• Regulatory Affairs
• Clinical Studies
• Compliance Assessment
• Document Review
• IRB/EC Submissions
• Regulatory Body Submissions
• Documentation Management
• ICH/GCP
• Communication Skills
• Problem-Solving
• Team Collaboration

Location

• Australia

Work Type

• Hybrid

Experience Level

• 3-5 years

Education Level

• Associate's Degree
• Bachelor's Degree

Benefits

• Career progression support
• Mentoring program
• Program for recent graduates
• Tuition assistance
• Partnership with universities and colleges
• Dedicated training department
• Guaranteed full pay during COVID-19 shutdown
• Work-life balance support
• Generous vacation time
• Hybrid work from home schedule

About the Company

• CTI is a leading CRO with a global reach, operating in 60 countries.
• CTI focuses on treatments for chronically and critically-ill patients.
• CTI has experienced consistent double-digit growth over the last decade.
• CTI invests in cutting-edge technology.
• CTI has an average annual retention rate of 95%.
• CTI has received multiple awards recognizing it as a best place to work and a top CRO.