Thermo Fisher Scientific

Senior Regulatory Affairs Specialist - Central Labs

Belgium

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical Devices, Laboratory ServicesIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent formal academic/vocational qualification, and have previous experience comparable to 5+ years. Strong English language skills (written and oral) are required, along with solid attention to detail and quality, as well as strong editorial/proofreading skills.

Responsibilities

The Senior Regulatory Affairs Specialist will serve as a senior contact within the Global Central Labs at CRG, providing regulatory expertise and guidance to clients, ensuring compliance with FDA/IVDR, CE regulations, CAP, and CLIA standards. They will prepare and review regulatory guidance, provide regulatory strategy and technical advice, lead the development of project-specific processes, collaborate with internal and external clients, and participate in project meetings. Additionally, they will support business development activities and provide training and guidance to junior team members.

Skills

Regulatory Strategy

Regulatory Guidance

FDA

IVDR

CE Regulations

CAP

CLIA Standards

Regulatory Liaison

Project Management

Communication Skills

Attention to Detail

Proofreading

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.

Key Metrics

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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