[Remote] Sr. Ctry Approval Spec at Thermo Fisher Scientific

Igołomia-Wawrzeńczyce, Lesser Poland Voivodeship, Poland

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Skills

Key technologies and capabilities for this role

Regulatory SubmissionsClinical TrialsEC SubmissionsGene TherapyViral SafetyImport LicensesRegulatory StrategyProject CoordinationCommunicationComplianceInformed Consent Forms

Questions & Answers

Common questions about this position

What is the work arrangement or location policy for this role?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What education and experience are required for this position?

A Bachelor's degree or equivalent and relevant formal academic qualifications are required.

What salary or compensation does this role offer?

This information is not specified in the job description.

What are the main responsibilities in this Sr. Ctry Approval Spec role?

The role involves managing preparation, review, and coordination of country submissions, providing local regulatory strategy advice, developing submission strategies, and serving as the primary contact for investigators and regulatory authorities.

What makes a strong candidate for this position?

Strong candidates will have a Bachelor's degree with relevant experience in regulatory submissions, expertise in local regulatory processes, and the ability to coordinate with internal teams, investigators, and authorities while mentoring others.

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.

Land your dream remote job 3x faster with AI