Principal Regulatory Affairs Specialist – Regulatory Liaison

🔥 24 minutes ago

🌐 South Africa, Romania, +6 more countries – Remote

🇿🇦 South Africa – Remote 🇷🇴 Romania – Remote 🇬🇷 Greece – Remote 🇨🇿 Czechia – Remote 🇺🇦 Ukraine – Remote 🇮🇹 Italy – Remote 🇵🇹 Portugal – Remote 🇱🇻 Latvia – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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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

• Provides regulatory advice and carries out projects in the provision of regulatory affairs services • Acts as liaison with internal stakeholders in the provision of regulatory affairs services • Performs day-to-day operational aspects of the Regulatory Affairs Department, including assessment of regulatory documents, preparation and assembly of global regulatory submissions, and QC review of final submission packages • Interfaces with PPD project teams and Health Authorities regarding regulatory strategy and submission activities • Develops and maintains cooperative working relationships with Project Managers and project team members for assigned projects • Advises and directs project teams regarding responsibilities related to regulatory strategy and submission activities • Acts as a key liaison between the Regulatory Affairs Department and project teams for assigned projects

🎯 Requirements

• Bachelor's Degree; degree in Pharmacy or Life Science is an advantage • Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered • Some regulatory affairs experience is preferable but not mandatory • Appreciation of requirements, timelines and processes for regulatory applications globally • Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage • Excellent English language communication skills, both verbal and in writing • Computer skills (Microsoft Office) • Experience in applications used in clinical trials (eTMF, CTMS) would be an advantage • Good organizational and planning skills • Ability for multiple project tasking • Proven ability to work effectively in a team, including in a multinational one • Problem solving skills and strong attention to detail