Senior Regulatory and Start Up Specialist, Brazil

Precision Medicine Group

Senior regulatory specialist launching clinical trial sites in Brazil for Precision Medicine Group. Managing submissions, essential documents, site activation, and local regulatory compliance.

Posted 8/6/2026full-timeRemote • 🇧🇷 BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory processes, site activation, and clinical trial management, with a strong focus on compliance with Good Clinical Practice and ICH Guidelines. Proficient in preparing and managing essential documents, communication with regulatory bodies, and maintaining audit readiness.

Highest-signal resume keywords

Regulatory Submission ManagementClinical Trial Application PreparationGood Clinical Practice KnowledgeProject Management SkillsProfessional-Level English Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionClinical Trial ApplicationSite ActivationDocument ManagementRegulatory IntelligenceBudget NegotiationEssential Document ReviewKnowledge of Local Clinical Trial LawsAudit ReadinessFeasibility Assessment

Soft Skills

Excellent CommunicationOrganizational SkillsAbility to Prioritize WorkloadEffective Team InteractionIndependence in Fast-Paced Environment

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord Processing SoftwareElectronic Mail

Certifications & Qualifications

Bachelor’s Degree in Life SciencesRegistered Nurse (RN)

Industry Keywords

CROPharmaceutical IndustryBiotech IndustryICH GuidelinesGood Clinical PracticeRegulatory Requirements

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Occasional travel may be required
Equal Opportunity Employer
Reasonable accommodation available for applicants with disabilities