Senior Country Approval Specialist

🔥 3 minutes ago

🇬🇧 United Kingdom – 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 guidelines and processes are followed for internal, investigator and regulatory-authority communications • Act as key country-level 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 submission timelines with site activation critical paths • Achieve target cycle times for site activations • Prepare regulatory compliance review packages • Coordinate local submission activities in accordance with global project submission strategy • Develop country-specific Patient Information Sheet/Informed Consent Form documents • Assist with grant budgets and site 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 PPD WPD or client SOPs • Maintain knowledge of PPD and 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 the knowledge, skills, and abilities to perform the job • Appropriate education, training and/or directly related experience may be considered as an equivalency • 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 • Ability to work in an office/laboratory and/or clinical environment • Potential exposure to biological fluids and infectious organisms • Personal protective equipment required, including protective eyewear, garments and gloves

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused workplace • Personal protective equipment such as protective eyewear, garments and gloves

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