[Remote] Senior/Principal Regulatory Affairs Specialist (Clinical Trial Applications) at Thermo Fisher Scientific

Serbia

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Medical DevicesIndustries

Skills

Key technologies and capabilities for this role

Regulatory AffairsClinical Trial Applications (CTA)Global Regulatory Guidelines (ICH)Regulatory SubmissionsRegulatory StrategyLiterature ReviewProject ManagementTeam CollaborationMicrosoft WordMicrosoft ExcelMicrosoft PowerPointAnalytical SkillsProblem-SolvingAttention to DetailInterpersonal SkillsIndependent Judgment

Questions & Answers

Common questions about this position

What is the work location or arrangement for this role?

The position is Global (Hybrid), allowing for a mix of remote and on-site work across global locations.

What is the salary for this position?

This information is not specified in the job description.

What key skills are required for this role?

Required skills include excellent command of English, exceptional interpersonal skills for teamwork, strong organizational and time management skills, advanced computer skills in Microsoft Office, and analytical problem-solving abilities.

What is the company culture or mission at Thermo Fisher Scientific?

Thermo Fisher Scientific's mission is enabling customers to make the world healthier, cleaner, and safer, with a focus on global clinical trials in 100+ countries and collaborative teamwork.

What makes a strong candidate for this position?

A strong candidate will have previous regulatory affairs experience, knowledge of global clinical trial requirements and ICH guidelines, a Bachelor’s or advanced degree, and skills in independent judgment, teamwork, and regulatory submissions.

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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