Thermo Fisher Scientific
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
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.
Senior/Principal Country Approval Specialist
Job not on LinkedIn
🔥 13 minutes ago
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Thermo Fisher Scientific
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
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 • Provide local regulatory strategy advice to internal clients • Develop and implement local submission strategy • Serve as primary contact for investigators • Ensure guidelines and processes are followed for effective team communications • Act as a key-contact at country level for all submission-related activities • Participate in Submission Team Meetings, Review Meetings, and Project Team meetings • Coordinate with internal functional departments to ensure alignment of submission process • Achieve company’s target cycle times for site activations • Prepare regulatory compliance review packages • Maintain knowledge of PPD SOPs, Client SOPs/directives, and current regulatory guidelines
🎯 Requirements
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience (2+ years for Senior or 5+ years for Principal) in CRO/Sponsor setting • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail • Good negotiation skills • Good computer skills • Good English language and grammar skills • Good judgment and decision-making skills
🏖️ Benefits
• Standard work schedule (Mon-Fri) • Opportunities for professional development
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