Senior Regulatory Writer

1 week ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $115,094 - $144,333
Key Position for Regulatory Document Expertise

Certara accelerates drug development through proprietary biosimulation software and services, transforming traditional processes. As a senior regulatory writer, you will play a key role in authoring clinical documents across various therapeutic areas.

Major Responsibilities:
  • Develop effective strategies for organizing and preparing regulatory documents with client and internal teams.
  • Author high-quality documents based on client specifications, templates, style guides, and regulatory authority guidelines.
  • Act as a trusted advisor to clients, building strong relationships through consistent communication.
  • Maintain open collaboration with both client and internal teams.
  • Provide coaching to junior staff and ensure compliance with company SOPs and training requirements.

Essential Qualifications:
  • Bachelor's degree; MS or PhD preferred.
  • 8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD.
  • Strong understanding of regulatory authority guidelines and requirements.
  • Experience in submission-level document development (does not require functioning as a document lead).
  • Vaccine & Immunogenicity Regulatory Writing Experience is highly desirable.

Desirable Skills & Abilities:
  • Intermediate proficiency with Microsoft Word skills and document management techniques.
  • Ability to synthesize data across multiple sources and create summary reports.
  • Able to own submission-level sections and take responsibility for clarity of purpose.
  • Demonstrate an understanding of communication best practices and coaching others on communication implications.
  • Ability to identify and institutionalize work practices for consistency in performance.
  • Possesses broad experience and technical expertise across more than one therapy area.

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