Principal Country Approval Specialist

🔥 0 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🔴 Lead

✨ Principal

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.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

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy • Provide local regulatory strategy advice to internal clients • Provide project-specific 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, review and project team meetings • Coordinate site start-up activities with internal functional departments • Achieve company target cycle times for site activations • Prepare regulatory compliance review packages with start-up CRAs • 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 databases • Oversee country study files for compliance with PPD WPD or client SOPs • Maintain knowledge of company and client SOPs and current regulatory guidelines • Direct or mentor other SIA team members • 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, or comparable knowledge, skills, and abilities • Combination of 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 • 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 regulatory guidelines and EC regulations

🏖️ Benefits

• Award-winning learning and development program • Professional and personal career growth opportunities • Diverse, inclusive team environment • Collaboration with a global team • Recognition of the power of being one team