FSP Country Approval Specialist
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From Thermo Fisher Scientific’s original posting
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals. What You’ll Do: • Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. • Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. • Provides project specific local SIA services and coordination of these projects. • May have contact with investigators for submission…
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