Country Approval Specialist

🔥 10 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Prepare, review, and coordinate local regulatory submissions, including Ministry of Health, Ethics Committee, gene therapy approvals, viral safety dossiers, and import licenses, in alignment with the global submission strategy • Provide local regulatory strategy advice to internal clients under guidance • Provide and coordinate project-specific local SIA services • Contact investigators for submission-related activities as needed • Serve as the country-level key contact for ethical or regulatory submission activities • Coordinate with internal functional departments to align site start-up activities with submission activities and agreed timelines • Align submission processes for sites and studies with the critical path for site activation • Achieve PPD target cycle times for sites • Work with start-up CRAs to prepare regulatory compliance review packages when applicable • Develop country-specific Patient Information Sheets and Informed Consent forms when applicable • Assist with grant budget and site payment schedule negotiations • Support feasibility activity coordination according to agreed timelines • Enter and maintain trial status information for SIA activities in PPD tracking databases • Prepare, establish, and maintain local country study files and filing processes according to PPD WPDs or client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives, and applicable regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 2+ years of previous relevant experience, or comparable knowledge, skills, and abilities • An equivalency combining appropriate education, training, and/or directly related experience may satisfy requirements • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and ability to learn appropriate software • Good English language and grammar skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, under direction, as required • Basic organizational and planning skills • Basic knowledge of applicable regional/national regulatory guidelines and EC regulations • Ability to work in an office/laboratory and/or clinical environment • Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule

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