Senior/Principal – Country Approval Specialist

🔥 10 minutes 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 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 with internal departments • Serve as primary contact for investigators and local regulatory authorities • Ensure regulatory guidelines, processes, and communications are followed • 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 • Achieve target cycle times for site activations • Prepare regulatory compliance review packages • Coordinate local submission activity in accordance with global project strategy • Develop country-specific Patient Information Sheets and Informed Consent Forms • Assist with grant budgets and payment schedule negotiations • Identify local out-of-scope contract 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 SOPs • Maintain knowledge of company and client SOPs, directives, and regulatory guidelines • Direct or mentor SIA individuals assigned to projects • Identify, resolve, or escalate regulatory process issues

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Senior level: 2+ years direct startup experience in CRO/Sponsor setting or comparable to 5+ years relevant experience • Principal level: 5+ years direct startup experience in CRO/Sponsor setting or comparable to 8+ years relevant experience • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • 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 • Basic organizational and planning skills • Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations

🏖️ Benefits

• Collaboration and development opportunities • Global team environment • Scientific excellence-focused workplace

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