Principal Country Approval Specialist

🔥 29 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🔴 Lead

🏥 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, including MoH, EC and applicable special national applications • Provide local regulatory strategy advice to internal clients • Provide project-specific local submission strategy, technical expertise and coordination oversight • Serve as primary contact for investigators and local regulatory authorities • Ensure submission guidelines, processes and communications are followed • 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 submissions with site activation timelines • Achieve company target cycle times for site activations • Work with start-up CRAs to prepare regulatory compliance review packages • Develop country-specific Patient Information Sheets and Informed Consent Forms • Assist with grant budgets and payment schedule negotiations with sites • Identify local out-of-scope contract activities and advise relevant functions • Support feasibility activities according to agreed timelines • Maintain accurate and current trial status information for SIA activities in the database • Oversee country study files and ensure compliance with PPD WPD or client SOPs • Maintain knowledge of company and client SOPs, directives and current regulatory guidelines • Direct or mentor other SIA team members assigned to projects • Prepare and maintain country master document templates and regulatory intelligence systems

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job • 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 • Solid negotiation skills • Good computer skills and ability to learn appropriate software • Good English and Polish 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 • Good organizational and planning skills • Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations

🏖️ Benefits

• Award-winning learning and development program • Professional and personal career development opportunities • Diverse, inclusive environment where diverse experiences, backgrounds and perspectives are valued

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