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Senior Regulatory Publishing Specialist

1 miesiąc temu

Poland MyGwork Pełny etat
Regulatory Publishing Specialist Job Description

This role is with Thermo Fisher Scientific, a company committed to diversity and inclusion, and a member of MyGwork – the largest global platform for the LGBTQ+ business community.


Please do not contact the recruiter directly.


Job Overview

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.


Our Mission

We enable our customers to make the world healthier, cleaner, and safer.


Key Responsibilities

The Senior Regulatory Publishing Specialist provides expert strategic, expedient, and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional, and ICH regulatory and technical requirements.


Key responsibilities include:



  • Ensuring successful regulatory review outcomes for product milestones.
  • Serving in a quality review role and responsible for the thorough review of documents created within or outside of the company to ensure quality of standards meet or exceed client expectations
  • Providing expertise in client submission deliverables supporting regulatory compliance.
  • Maintaining document life cycle for submission documents.

Requirements

The ideal candidate will have:



  • A Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • Strong knowledge of regulatory requirements and guidances for document management and electronic submissions.
  • Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, e CTD validation and viewing tools.
  • Ability to manage several complex projects in parallel and adapt to changing priorities.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.


Why Work with Us?

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.


#Start Your Story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.