16 matching jobs for “FSP Country Approval Specialist”

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Exact titles rank first, then title variations and keywords in descriptions. These labels aren't qualification scores. Without keywords, recently added jobs appear first.

Thermo Fisher Scientific

FSP Country Approval Specialist

Remote, Romania

Join us as a Country Approval Specialist and make an impact at the forefront of innovation. We have successfully supported the …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approval Specialist - FSP

Austria, Austria +1 location 2 postings

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top …

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Country Approval Specialist

Remote, North Carolina, USA +4 locations 17 postings

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approval Specialist - FSP

Remote, United Kingdom

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top …

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Country Approval Specialist II

Remote, Denmark

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approval Specialist - FSP - Portugal

Lisbon, Portugal

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top …

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Bench Country Approval Specialist

Remote, Mexico +3 locations 4 postings

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approval Specialist - FSP- Israel

Remote, Israel

… minimize delays, and execute high-quality, cost-efficient clinical studies. Position Overview: As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approval Specialist/ Sr. Country Approval Specialist - FSP client dedicated

Sofia, Bulgaria +2 locations 3 postings

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top …

Added Oct 16, 2026

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Thermo Fisher Scientific

Country Approval Specialist-FSP-Belgium/ Netherlands

Brussels, Belgium +1 location

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top …

Added Oct 20, 2026

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Thermo Fisher Scientific

FSP Country Approval Specialist (all level)

Remote, Singapore

Join Us as a Country Approval Specialist - Make an Impact at the Forefront of Innovation The Country Approval Specialist manages …

Added Oct 16, 2026

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Thermo Fisher Scientific

FSP Principal Contract Specialist

Remote, North Carolina, USA

Join Us as a Principal Site Contract Specialist - Make an Impact at the Forefront of Innovation The Principal Site Contract Specialist leads the …

Added Oct 16, 2026

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IQVIA Holdings

RSU Specialist I, FSP Sponsor Dedicated

Mexico City, Mexico

Regulatory & Start Up Specialist 1, cFSP - Global Support Mexico - Full Home Based role Purpose: The RSU Specialist 1 proactively drives and …

Added Oct 15, 2026

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Thermo Fisher Scientific

Sr. Site Contract Specialist - FSP client dedicated

Sofia, Bulgaria +2 locations 3 postings

Join Us as Senior Site Contract Specialist- Make an Impact at the Forefront of Innovation The Senior Site Contract Specialist manages the preparation, …

Added Oct 16, 2026

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IQVIA Holdings

Regulatory and Start Up Specialist - Poland

Warsaw, Poland

… sites, Site Activation Managers, Project Managers, and internal stakeholders. Coordinate and execute country-specific site activation and regulatory activities. Prepare, review, and distribute regulatory …

Added Oct 15, 2026

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IQVIA Holdings

Regulatory and Start Up Specialist with Contracts - Hungary

Budapest, Hungary

Added Oct 15, 2026

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Thermo Fisher Scientific

FSP Country Approval Specialist

Remote, Romania

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About this opportunity

Original employer description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Country Approval Specialist and 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 will do:

Prepare, review and coordinate 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 EU/global submission strategy
Provide local regulatory strategy advice (MoH &/or EC) to internal clients
Provide project specific local start-up services and coordination of these projects
May have contact with investigators for submission related activities
Serve as key-contact at country level for either Ethical or Regulatory submission-related activities
Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation
Achieve target cycle times for site activation
Prepare the regulatory compliance review packages, if applicable
Develop country specific Patient Information Sheet/Informed Consent form documents
May assist with grant budget(s) and payment schedules negotiations with sites
May support the feasibility activities, as required, in accordance with agreed timelines
Enter and maintain trial status information relating to start-up activities onto the study specific tracking databases in an accurate and timely manner
Ensure the local country study files and filing processes are prepared, set up and maintained as per applicable SOPs
Maintain knowledge of and understand SOPs, client directives, and current regulatory guidelines as applicable to services provided

Education and experience:

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Knowledge, skills and abilities:

Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations

Working conditions and environment:

Work is performed in an office environment
Exposure to electrical office equipment

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Exact title match

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