Senior Country Approval Specialist

United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must possess a Bachelor's degree or equivalent and have at least 5 years of relevant experience. Strong skills in communication, interpersonal interactions, attention to detail, negotiation, computer use, and decision-making are essential. Proficiency in English, including grammar, is also required.

Responsibilities

The Senior Country Approval Specialist will manage the preparation, review, and coordination of local regulatory submissions, including those for the Ministry of Health and Ethics Committees. They will provide strategic advice on local regulatory matters, develop and implement submission strategies, and act as the primary contact for investigators and local regulatory authorities. Responsibilities also include ensuring compliance with guidelines, coordinating site start-up activities, and developing country-specific patient information and informed consent documents.

Skills

Regulatory Submissions

Clinical Trials

MoH Submissions

EC Submissions

Gene Therapy

Viral Safety

Import Licenses

Regulatory Strategy

Project Coordination

Technical Expertise

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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