Country Approval Specialist - FSP dedicated - EMEA

Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

A Bachelor's degree and at least 2 years of comparable experience are required. Strong attention to detail, excellent oral and written communication skills, good negotiation skills, and computer proficiency are essential. Basic knowledge of regional/national regulatory guidelines, EC regulations, medical terminology, and organizational/planning skills are also necessary.

Responsibilities

The Country Approval Specialist will prepare, review, and coordinate local regulatory submissions, including MoH and EC applications, and provide local regulatory strategy advice. They will manage project-specific local SIA services, liaise with investigators for submission activities, and coordinate with internal departments to align site start-up with submission timelines. Responsibilities also include ensuring alignment with the critical path for site activation, maintaining trial status information, and managing local country study files according to PPD WPDs or client SOPs. The specialist will also maintain knowledge of PPD SOPs, client SOPs/directives, and current regulatory guidelines.

Skills

Regulatory Submissions

Attention to Detail

Accuracy

MoH Submissions

EC Submissions

Gene Therapy Approvals

Viral Safety Dossiers

Import License

Clinical Research

Site Activation

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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