Regulatory Start-Up Specialist, Clinical Trials

Precision Medicine Group; Townsville City; On-site; AUD 70,000 - 90,000; Full time

Job summary

A leading clinical research organization in Townsville City is seeking a Regulatory and Start Up Specialist. This role involves preparing clinical trial application forms, communicating with authorities, and maintaining project plans. The ideal candidate should have a Bachelor's degree in life sciences, strong communication skills, and at least 1 year of regulatory experience. Join the team to be part of groundbreaking cancer therapies.

Qualifications

• 1 year or more as a Regulatory or SU specialist in CRO or pharmaceutical/biotech.
• Experience with regulatory submissions and contract negotiations.
• Advanced degree in medical or life sciences preferred.

Responsibilities

• Prepare Clinical Trial Application Forms and submission dossiers.
• Interact with Competent Authorities and Ethics Committees.
• Maintain project plans and regulatory intelligence tools.

Skills

Strong communication and organizational skills

Experience using computerized information systems

Fluency in English

Education

Bachelor’s degree in life sciences or related field

Qualification in Pharmacy

Tools

Electronic spreadsheets

Word processing

Job description

A leading clinical research organization in Townsville City is seeking a Regulatory and Start Up Specialist. This role involves preparing clinical trial application forms, communicating with authorities, and maintaining project plans. The ideal candidate should have a Bachelor's degree in life sciences, strong communication skills, and at least 1 year of regulatory experience. Join the team to be part of groundbreaking cancer therapies.