Regulatory Affairs Study Start Up Specialist II

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

Regulatory Affairs Study Start Up Specialist II

Job Category: Regulatory Affairs SSU

Requisition Number: REGUL001941

• Posted : July 21, 2026
• Full-Time
• Hybrid

Locations

Showing 1 location

Sydney, Australia

Description

Please do not apply if you are not fully eligible to work in Australia. CTI doesn't offer any Sponsorship.

What you’ll do:

• Assist/Advise project teams on all regulatory requirements for clinical studies
• Perform compliance assessments according to country requirements and document any activity discovered; notify ProjectManagers of any findings
• Review and adapt study specific documents according to each country and site requirements
• Perform IRB/EC(CA) and/or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements
• Receive and process study documentation from sites, check content and quality as well as completeness
• Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review
• Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
• Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level
• Assist in preparation, quality check and filing of site adapted ICF according to local requirements
• Prepare and QC Clinical Trial Application forms (e.g. CTA, XML) where applicable
• Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
• Respond to Deficiency Letters from IRB/IEC/CA and/or other Regulatory Bodies in liaison with sponsor and study PM or assists sites in their response to IRB according to country and site requirements
• Compiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
• Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed
• Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
• Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
• Assist with preparation for Sponsor or Agency audits and inspections
• Assist with QC and QA of various study related Regulatory documents and reports
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
• Attend internal and external study meetings and regulatory status reports for each site and country during study meetings
• Sites budgets and Sites contracts management, depending from Countries/Regions

What you bring:

• 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,
• Ability to develop, prioritize, organize, and manage multiple tasks
• Decision making and creative problem-solving skills
• Working knowledge and understanding of applicable country regulations, International Council on Harmonization (ICH) / Good Clinical Practice (GCP) regulations and guidelines

Why CTI?

• We support career progression - We Believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
• We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time and a hybrid work from home schedule
• We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
• We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
• Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market