Thermo Fisher Scientific

Regulatory Publishing Specialist

Philippines

Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Regulatory AffairsIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent formal academic/vocational qualification, along with at least 5 years of relevant experience. A strong understanding of regulatory requirements and guidances for document management and electronic submissions is essential, as is advanced knowledge of Microsoft Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools, and advanced knowledge of electronic templates and skilled in formatting and troubleshooting templates.

Responsibilities

The Regulatory Publishing Specialist will prepare components of electronic regulatory submissions to meet regulatory requirements, maintain document life cycles for submission documents, lead the development and implementation of project-specific processes for sponsors, and potentially act as the company’s liaison for regulatory submissions with sponsors and assist project teams in executing regulatory submission strategies, providing leadership through training and mentoring, using professional judgment to evaluate publishing needs, engaging with project teams to deliver final products and resolve issues, and working independently or as a project team lead to evaluate and deliver publishing tasks.

Skills

Regulatory Submission
Electronic Publishing
Document Management
Regulatory Compliance
Project Management
Quality Review
Software Proficiency (sponsor and regulatory agency software)

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.

Key Metrics

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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