Career Opportunities

Regulatory Affairs/Medical Writer

Hybrid/Onsite; Consultant or Full Time

The Regulatory Affairs Associate will perform the preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submission documents for investigational, new and marketed drugs and support regulatory operations submissions activities.

Your Contributions (include, but are not limited to):

  • Performs the formatting, compilation, and publication of regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards by creating bookmarks, hypertext links, etc. using document templates, eCTD publishing tools and document management systems
  • Performs quality control checks of documents and regulatory submissions to ensure compliance with ICH, FDA and company defined standards
  • Acquires skills, knowledge and experience of increasingly complex documents, applications and submission types, beginning with amendments to existing applications through marketing applications and beyond
  • Develops knowledge and experience of submission types for global regulatory applications and submissions in accordance with corporate needs
  • Maintains regulatory submissions, correspondence, and document publishing tracking logs
  • Imports submissions into shared document management system
  • Assists as needed with any regulatory initiatives and monitors regulatory submission timelines and deliverables
  • Learns and keeps abreast of updates to regulatory guidance, laws, and best practices related to job functionality
  • Provides support and training to end users as needed on template usage, eCTD format and general processes that support regulatory submissions


  • BS/BA degree in a scientific or closely related field and some relevant experience
  • Strong knowledge of Microsoft Office programs, use of Microsoft Word Templates and Adobe Acrobat, required
  • Experience with publishing of regulated documents and electronic submissions preferred
  • Ability to manage time efficiently and work independently
  • Understands importance of meeting deadlines
  • Has good knowledge of document publishing and regulatory submission requirements
  • Has developed skills and abilities with tools used in regulatory operations


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