Regulatory Publishing Specialist (Advanced Word Formatting)

Mexico

Apply with AI Apply

Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

Candidates must possess a Bachelor's degree or equivalent, with at least 2 years of relevant experience. A strong understanding of regulatory requirements for document management and electronic submissions is necessary. Proficiency in Microsoft Word, Excel, Adobe Acrobat, electronic document management systems, document publishing tools like ISIToolbox, publishing systems such as docuBridge and Veeva Submission Publishing, and eCTD validation/viewing tools is required. The ability to format and troubleshoot electronic templates, manage multiple complex projects, adapt to changing priorities, and exercise independent judgment is essential. Strong organizational, interpersonal, and analytical skills are also necessary.

Responsibilities

The Regulatory Publishing Specialist will prepare electronic submission deliverables and dossiers that meet current local, regional, and ICH regulatory and technical requirements, ensuring successful regulatory review outcomes. This role involves coordinating and managing electronic submission deliverables, assisting in preparing electronic document outputs compatible with sponsor and regulatory agency software, and ensuring final deliverables meet current regulatory electronic document requirements and guidance. The specialist will also assist in developing and implementing project-specific processes, act as a liaison for electronic submissions, evaluate publishing needs in relation to project timelines, quality, and delivery, and engage project team members to resolve issues and deliver the final product.

Skills

Regulatory Publishing

Electronic Submissions

Dossier Preparation

ICH Guidelines

Word Formatting

Quality Review

Project Management

Client Communication

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

Try Jobo Free