Country Approval Specialist at Thermo Fisher Scientific

Prague, Prague, Czechia

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's degree
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Effective oral and written communication skills
Excellent social skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations

Responsibilities

Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS (and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy
Provides, under guidance, local regulatory strategy advice (MoH &/or EC) to internal clients
May have contact with investigators for submission related activities
Key-contact at country level for either Ethical or Regulatory submission-related activities
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
Achieves PPD’s target cycle times for site
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
May develop country specific Patient Information Sheet/Informed Consent form documents
May assist with grant budgets(s) and payment schedules negotiations with sites
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines
Enters and maintains trial status information relating to start up activities onto PPD tracking databases in an accurate and timely manner
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Skills

Key technologies and capabilities for this role

EU CTISRegulatory SubmissionsGene Therapy ApprovalsMoHECClinical Trial SubmissionsSite ActivationRegulatory Strategy

Questions & Answers

Common questions about this position

What education is required for the Country Approval Specialist role?

A Bachelor's degree is required, along with previous experience that provides the knowledge, skills, and abilities to perform the job, comparable to 2+ years.

Is this a remote position or does it require office work?

The position is based in office environmental conditions with a standard Monday-Friday work schedule.

What are the main responsibilities of a Country Approval Specialist?

The role involves preparing, reviewing, and coordinating regulatory submissions to EU CTIS and local applications, providing local regulatory strategy advice, coordinating with internal departments for site start-up activities, and maintaining trial status information.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work that positively impacts global health, provides resources for career goals, and fosters a collaborative environment focused on research, development, and delivery of life-changing therapies.

What makes a strong candidate for this position?

Strong candidates have a Bachelor's degree, 2+ years of relevant experience, strong attention to detail, and the ability to take ownership of document accuracy while working under guidance on 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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