Ctry Approval Specialist

Igołomia-Wawrzeńczyce, Lesser Poland Voivodeship, Poland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

Candidates must possess a Bachelor's degree or equivalent, with at least 2 years of relevant experience. Strong skills in communication, interpersonal interactions, attention to detail, negotiation, and computer literacy are essential. A basic understanding of medical terminology, regulatory guidelines, and the ability to work independently or in a team are also required.

Responsibilities

The Ctry Approval Specialist will manage and prepare country-specific regulatory submissions, including EC and other national applications, aligning with global strategies. They will provide local regulatory advice, coordinate site start-up activities, and liaise with investigators and internal departments to ensure timely progress. Responsibilities also include maintaining trial status information, ensuring compliance with SOPs and regulatory guidelines, and potentially assisting with patient information documents and grant negotiations.

Skills

Regulatory Submissions

EC Submissions

Gene Therapy

Viral Safety

Import License

Regulatory Strategy

Project Coordination

Investigator Communication

Ethical Submissions

Functional Department Coordination

Site Activation

Regulatory Compliance

Patient Information Sheet

Informed Consent Form

Grant Budgets

Payment Schedules

Feasibility Activities

Database Management

Filing Processes

SOPs

Regulatory Guidelines

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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