Ctry Approval Spec

Mexico

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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, HealthcareIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent, with at least two years of relevant experience. Essential skills include effective communication, strong attention to detail, good negotiation abilities, computer proficiency, and a solid understanding of English grammar. Basic knowledge of medical terminology, regulatory guidelines, and the ability to work independently or in a team are also required.

Responsibilities

The Country Approval Specialist will manage and prepare country submissions according to global strategies, including Ministry of Health (MoH) and Ethics Committee (EC) applications. Responsibilities include providing local regulatory advice, coordinating submission activities with internal departments and external contacts, maintaining trial status information, and ensuring compliance with regulatory guidelines and standard operating procedures.

Skills

Regulatory Submissions

MoH Submissions

EC Submissions

Clinical Trials

Regulatory Strategy

Project Coordination

Documentation

Compliance

SOPs

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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