Senior Regulatory and Start Up Specialist, Brazil
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Job Description
Senior regulatory specialist managing clinical-trial submissions and site activation for Precision for Medicine in Brazil. Supporting compliance, essential documents, contracts, and country start-up activities.
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 study leads and project teams
- Maintain project plans, trackers, and regulatory intelligence tools
- Support study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with 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
- Act as subject matter expert for site activation critical-path data, regulatory timelines, contracts, budgets, and required reviews
- Support study budget negotiation 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, mentoring, client updates, and proposal activities as needed
- 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 as a Regulatory or Site Start-Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
- Professional-level English communication skills, verbal and written
- Fluency in English and the local language of the country where the position is based
- Excellent communication and organizational skills
- Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail
- 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
- Excellent written and spoken communication, presentation, and interpersonal skills
- Flexible attitude toward work assignments and learning
- 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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