Senior Regulatory Affairs Specialist – Regulatory Liaison

🔥 0 minutes ago

🇭🇷 Croatia – Remote

⏰ Full Time

🟠 Senior

🚔 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

• Provide regulatory advice and carry out projects in the provision of regulatory affairs services • Act as liaison with internal stakeholders in providing regulatory affairs services • Perform day-to-day operational aspects of the Regulatory Affairs Department, including assessment of regulatory documents • Prepare and assemble global regulatory submissions • Conduct quality-control review of final submission packages • Interface with PPD project teams and Health Authorities regarding regulatory strategy and submission activities • Develop and maintain cooperative working relationships with Project Managers and project team members • Advise and direct project teams on responsibilities related to regulatory strategy and submission activities • Act as 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 • Previous Regulatory affairs experience • Appreciation of the requirements, timelines and processes for regulatory applications globally is a valuable asset • 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

🏖️ Benefits

• Fully remote work arrangement • Standard Office Hours (40/wk)