Senior Regulatory and Start Up Specialist, Brazil
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Job Description
Senior regulatory specialist launching clinical trial sites in Brazil for Precision Medicine Group. Managing submissions, essential documents, site activation, and local regulatory compliance.
Responsibilities:
- Deliver timely, high-quality site activation readiness for assigned country/sites and mitigate risks
- Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies
- Interact with Competent Authorities and Ethics Committees and handle responses
- Provide submission updates to Start Up/Regulatory Leads and project teams
- Maintain project plans, trackers, regulatory intelligence tools, and regulatory leadership updates
- Support study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with assigned site CRAs to align communication and secure site collaboration
- Prepare, review, and manage essential documents for site activation and IMP release
- Customize country/site-specific Patient Information Sheets and Informed Consent Forms
- Coordinate translations of submission documents
- Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status and deliverables
- Act as subject matter expert for site activation critical-path data, regulatory timelines, contracts, budgets, and required reviews
- Support study budget negotiations and investigator contract execution when required
- Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge internally
- Maintain audit and inspection readiness and file documents in the relevant TMF
- Support Pre-Study Site Visits, site feasibility outreach, country start-up summaries, training sessions, and staff mentoring as needed
- Provide clients with activation-readiness updates and support proposal activities
- Perform other duties assigned by management
Requirements:
- Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience
- 3.5 years or more of Regulatory or Site Start-Up specialist experience in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
- Professional-level English proficiency in verbal and written communication
- Fluency in English and the local language for the country where the position is based
- Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail
- Excellent communication and organizational skills
- Ability to prioritize workload and meet deadlines
- Knowledge of Good Clinical Practice, ICH Guidelines, and applicable regulatory requirements
- Ability to interact effectively with project teams and communicate in English and the local language
- Ability to work independently in a fast-paced environment
- Excellent computer skills
- Occasional travel may be required
Benefits:
- Occasional travel may be required
- Equal Opportunity Employer
- Reasonable accommodation available for applicants with disabilities
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