Senior Regulatory and Start Up Specialist, Brazil

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• 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