Senior Country Approval Specialist

🔥 17 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 12%

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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 in alignment with global submission strategy • Provide local regulatory strategy advice to internal clients • Develop and implement local submission strategy • Provide technical expertise and coordination oversight in collaboration with internal departments • Serve as primary contact for investigators and local regulatory authorities • Ensure regulatory guidelines and processes are followed for internal and external communications • Act as country-level key contact for submission-related activities • Participate in submission, review and project team meetings • Coordinate site start-up activities with internal functional departments and agreed timelines • Ensure submission processes align with the critical path for site activation • Achieve company target cycle times for site activations • Prepare regulatory compliance review packages • Coordinate local submission activity in accordance with global project submission strategy • Develop country-specific Patient Information Sheet/Informed Consent form documents • Assist with grant budgets and payment schedule negotiations with sites • Identify local out-of-scope contractual activities and advise relevant functions • Support feasibility activities • Maintain accurate and current trial status information in the database • Oversee country study files and ensure compliance with PPD WPD or client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives and applicable regulatory guidelines • Direct or mentor other Start-Up individuals as appropriate • Identify, resolve or escalate issues in the regulatory process

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • 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 • Good judgment and decision-making skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, with minimal supervision • Ability to mentor fellow Start-Up team members • Excellent team player with teambuilding skills • Organizational and planning skills • Knowledge of applicable regional/national regulatory guidelines and EC regulations

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Commitment to scientific excellence

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