Principal Regulatory Affairs Specialist (Global Clinical Trial Applications)
Thermo Fisher Scientific · Remote
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Role summary
Principal Regulatory Affairs Specialist needed to lead global regulatory strategies for clinical trials across phases 1-4. This remote position in Serbia involves managing submissions, coordinating with sponsors and regulatory agencies, and providing strategic regulatory intelligence within a global clinical research organization.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 8+ years of experience in regulatory affairs or comparable relevant background
- Knowledge of global clinical trials landscape and ICH/regulatory guidelines
- Experience leading global regulatory projects for clinical trial applications
- Experience with bid defense meetings
- Fluent English (written and oral) and local language proficiency
- Advanced proficiency with Microsoft Office and ability to learn new technologies
What you'll be doing
- Prepare and assemble global regulatory submissions and clinical trial authorization documents
- Lead regulatory discussions and coordinate strategies across assigned clinical trial projects
- Interface with sponsors and clients to provide regulatory guidance and strategic intelligence
- Review and assess clinical trial documents and scientific literature for regulatory compliance
- Arrange, lead, and report on client and regulatory agency meetings
Privacy & handoff
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