[Remote] Country Approval Specialist - FSP at Thermo Fisher Scientific

Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent qualification, with previous experience demonstrating the necessary knowledge, skills, and abilities for the role. Effective oral and written communication skills, excellent interpersonal skills, and strong attention to detail are essential.

Responsibilities

The Country Approval Specialist will manage and prepare country regulatory submissions, including Ministry of Health and Ethics Committee applications, in alignment with global submission strategies. They will provide local regulatory strategy advice, coordinate site start-up activities with internal departments, and maintain accurate trial status information in tracking databases. Responsibilities also include ensuring local country study files are maintained according to PPD WPDs or client SOPs and staying current with PPD SOPs, client SOPs/directives, and relevant regulatory guidelines.

Skills

Regulatory Submissions

Clinical Trials

Attention to Detail

Accuracy

MoH Submissions

EC Submissions

Import License Applications

Gene Therapy Approvals

Viral Safety Dossiers

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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