Senior Regulatory and Start Up Specialist (Brazil)

Essential Functions:

• Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees.
• Manage collection and quality review of essential documents required for site activation and IMP release.
• Partner with site CRAs and other functions to ensure alignment and secure site collaboration.

Qualifications:

• Bachelor’s degree in life sciences or related field, or equivalent experience.
• Minimum 3.5 years of regulatory or site start-up experience in CRO or pharmaceutical/biotech.
• Fluency in English and Portuguese (local language) required.

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and local regulatory requirements.
• Excellent organizational and communication skills, with ability to prioritize workload.
• Ability to work independently in a fast-paced environment and adapt to changing priorities.