Senior Country Approval Specialist

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 and applicable special national applications • Provide local regulatory strategy advice to internal clients • Develop and implement local submission strategies • Provide technical expertise and coordination oversight with relevant internal departments • Serve as primary contact for investigators and local regulatory authorities • Ensure submission guidelines, processes and communications are followed • Act as country-level key contact for submission-related activities • Participate in Submission Team, Review and Project Team meetings • Coordinate site start-up activities with internal functional departments and align them with submission timelines and site activation critical paths • Achieve company target cycle times for site activations • Prepare regulatory compliance review packages • Coordinate local submission activity within SIA according to global project submission strategy • Develop country-specific Patient Information Sheets and Informed Consent Forms • Assist with grant budgets and payment schedule negotiations with sites • Identify out-of-scope contract activities and advise relevant functions • Support feasibility activities according to agreed timelines • 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 SIA individuals supporting assigned projects • Identify, resolve or escalate regulatory process issues and anomalies

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 5+ years of previous experience providing relevant knowledge, skills and abilities • Equivalent 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 SIA team members • Excellent team player with teambuilding skills • Basic organizational and planning skills • Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations • Willingness/ability to work in an office, laboratory and/or clinical environment • Ability to work with potential exposure to biological fluids and infectious organisms • Ability to use required personal protective equipment

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused workplace • Personal protective equipment provided/required, including protective eyewear, garments and gloves

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