FSP Country Approval Specialist

Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must possess a Bachelor's degree and at least 2 years of relevant experience. Required skills include effective oral and written communication, excellent social skills, strong attention to detail, good negotiation skills, and computer proficiency. A basic understanding of medical terminology, team collaboration, organizational planning, and knowledge of regional/national regulatory guidelines and EC regulations are also necessary.

Responsibilities

The Country Approval Specialist is responsible for preparing, reviewing, and coordinating local regulatory submissions, including MoH and EC applications, to activate investigative sites. This role involves providing local regulatory strategy advice, coordinating site start-up activities with internal departments, and ensuring alignment with global submission strategies and critical path timelines. Responsibilities also include maintaining trial status information, managing local country study files, and staying current with PPD SOPs, client SOPs, and regulatory guidelines.

Skills

Regulatory Submissions

Attention to Detail

Accuracy

MoH Submissions

EC Submissions

Gene Therapy Approvals

Viral Safety Dossiers

Import Licenses

Clinical Research

Project Coordination

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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