Senior Regulatory and Start Up Specialist, Brazil

Precision For Medicine

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.

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions, site activation processes, and compliance with local clinical trial laws. Proficient in managing essential documents, project plans, and communication with various stakeholders in the clinical research environment.

Highest-signal resume keywords

Regulatory SubmissionsSite Activation ProcessesGood Clinical PracticeClinical Trial Application PreparationProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory KnowledgeClinical Trial Application FormsEssential Document ManagementProject TrackingBudget NegotiationIMP Release RequirementsTranslation CoordinationSubmission Dossier PreparationAudit ReadinessSite Feasibility Assessment

Soft Skills

Excellent Communication SkillsOrganizational SkillsInterpersonal SkillsAbility to Prioritize WorkloadFlexible Attitude

Tools & Technologies

Computerized Information SystemsElectronic SpreadsheetsWord Processing SoftwareElectronic Mail

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nurse (RN)

Industry Keywords

CROPharmaceutical IndustryBiotech IndustryICH GuidelinesRegulatory 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 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

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 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

Comp & perks

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