Senior CMC Regulatory Technical Writer

6 days, 16 hours ago
Full-time
Lead
Technical Writing and Documentation
Excelya

Excelya

Excelya is a global CRO offering full-service, FSP, and Resourcing solutions to Biotech, Pharma, and Medical Device companies, prioritizing people-first healthcare advancements.

Professional Services
251-1K
Founded 2014

Description

  • Author, review, and finalize CMC documentation for Module 2.3 and Module 3 in Phase 3 and Marketing Authorization Applications.
  • Prepare briefing documents and responses to Health Authority questions as needed.
  • Collaborate with CMC technical teams to collect, interpret, and translate scientific and technical data into regulatory narratives.
  • Ensure documentation aligns with global regulatory requirements, including ICH, FDA, and EMA guidelines.
  • Develop, maintain, and improve CMC regulatory dossier templates in line with evolving guidelines.
  • Manage submission workflows within the electronic document management system in an eCTD environment.
  • Maintain consistency, accuracy, and scientific integrity across all regulatory documentation.
  • Manage timelines across multiple projects and proactively communicate risks.
  • Provide guidance and support to internal stakeholders when needed.

Requirements

  • Minimum 10 years of experience in CMC within the pharmaceutical industry and CMC regulatory technical writing.
  • Excellent writing, editing, and organizational skills.
  • Strong understanding of regulatory requirements and guidelines, including ICH, FDA, and EMA.
  • Ability to work collaboratively in a fast-paced environment.
  • Degree in Pharmacy or a relevant scientific field such as Chemistry, Biology, or equivalent.
  • Fluent written and spoken English.
  • Experience with CMC documentation for pharmaceutical regulatory submissions (preferred).
  • Experience working in an eCTD or electronic document management environment (preferred).

Benefits

  • Opportunity to join a young, ambitious health company of 900 employees.
  • Chance to contribute to a company aiming to become Europe’s leading mid-size CRO.
  • Exposure to a one-stop service model spanning full-service, functional service provider, and consulting projects.
  • Work alongside preeminent experts across scientific and operational disciplines.
  • Opportunity to develop through diverse projects.
  • Environment that values individual talents and supports personal growth.
  • Mission-driven work focused on improving the patient journey.

Interested in this position?

Apply directly on the company website

Apply Now

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