Regulatory Start-Up Expert – Hybrid

Consulting, Inc.; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Job summary

CTI in Sydney, Australia seeks a Regulatory Affairs Study Start Up Specialist II to support regulatory activities for clinical studies in multiple countries. The role requires coordinating submissions, document quality checks, and collaboration with sponsors and site teams across regions.

You will ensure compliance with ICH/GCP and country regulations, adapt study documents, and manage regulatory timelines.

Qualifications

• Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
• A 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 is a must

Responsibilities

• Assist/Advise project teams on all regulatory requirements for clinical studies
• Perform compliance assessments according to country requirements and document findings
• Review and adapt study documents for country/site requirements
• Submit regulatory documents (IRB/IEC/CA) on behalf of sponsors/sites as agreed
• Receive and process study documentation and ensure content quality and completeness
• Interact with site personnel for corrections or clarifications
• Compile regulatory documentation per CTI SOPs and sponsor requirements
• Assist with Informed Consent Form preparation and site adaptations
• Prepare and QC Clinical Trial Application forms where applicable
• Coordinate with Sponsors for regulatory submissions and responses
• Respond to deficiency letters in liaison with sponsor and PM
• Compile and assess completeness of regulatory packages for drug release
• Provide periodic status reports and attend project meetings
• Ensure correct study documentation in TMF systems
• Support audits and inspections preparation and QA of regulatory docs
• Oversee translation of regulatory documents if needed
• Attend study meetings and regulatory status updates

Skills

Regulatory knowledge

English proficiency

Cross-cultural teamwork

Attention to detail

Education

Bachelor’s degree in allied health or related field

Job description

CTI in Sydney, Australia seeks a Regulatory Affairs Study Start Up Specialist II to support regulatory activities for clinical studies in multiple countries. The role requires coordinating submissions, document quality checks, and collaboration with sponsors and site teams across regions.

You will ensure compliance with ICH/GCP and country regulations, adapt study documents, and manage regulatory timelines.