Regulatory Affairs Officer at Thermo Fisher Scientific

Tilburg, North Brabant, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechIndustries

Requirements

Proven experience in a similar role within the Pharmaceutical/BioTech industry for at least 3 years
Passion for problem-solving, attention to detail, and strong organizational skills
Sound understanding of GMPs and Manufacturing
Proficiency in writing, reviewing, and preparing full dossiers and submissions per EU guidelines
Familiarity with European national and MRP/DCP submissions and FDA legislation
Knowledge of GMP, EP, and US pharmacopeia
Experience with eCTD software for submission preparation
Excellent planning and communication skills in English; Dutch is a plus

Responsibilities

Collect, write, and maintain documents for regulatory submissions, ensuring compliance with GMP, company, and pharmaceutical guidelines
Prepare and submit CMC sections of registration dossiers and variations
Answer regulatory inquiries from partners
Initiate and handle change control records, with responsibility for progress of completed actions
Review specifications and Batch Master Records
Represent Regulatory Affairs as a core team member in new product development projects

Skills

GMP

CMC

eCTD

EU guidelines

MRP/DCP submissions

FDA legislation

EP pharmacopeia

US pharmacopeia

Batch Master Records

change control

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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