[Remote] Regulatory Publishing Specialist at Thermo Fisher Scientific

Philippines

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life SciencesIndustries

Requirements

Provides moderate, expedient, and efficient preparation of client electronic submission deliverables and dossiers that meet current local, regional, and ICH regulatory and technical requirements
Ensures successful regulatory review outcomes for product milestones
Serves in a quality review role
Responsible for the thorough review of documents created within or outside of the company to ensure quality standards meet or exceed client expectations

Responsibilities

Prepare client electronic submission deliverables and dossiers that meet current local, regional, and ICH regulatory and technical requirements in a moderate, expedient, and efficient manner
Ensure successful regulatory review outcomes for product milestones
Perform thorough quality review of documents created within or outside the company to ensure standards meet or exceed client expectations

Skills

Key technologies and capabilities for this role

Regulatory PublishingeCTDICH GuidelinesElectronic SubmissionsDossier PreparationQuality Review

Questions & Answers

Common questions about this position

What is the employment type for this position?

The position is full-time.

What is the work schedule and location for this role?

The work schedule is standard Monday through Friday in an office environment.

What are the main responsibilities of the Regulatory Publishing Specialist?

The role involves providing moderate, expedient, and efficient preparation of client electronic submission deliverables and dossiers that meet current local, regional, and ICH regulatory and technical requirements, ensuring successful regulatory review outcomes, and performing quality reviews of documents.

What kind of work environment can I expect at Thermo Fisher Scientific for this role?

The role is based in an office environment with a standard Monday-Friday schedule.

What salary or benefits are offered for this position?

This information is not specified in the job description.

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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