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Compass Consulting
Regulatory Submission Publishing SpecialistCompass Consulting • Pleasanton, CA, US
Regulatory Submission Publishing Specialist

Regulatory Submission Publishing Specialist

Compass Consulting • Pleasanton, CA, US
15 days ago
Job type
  • Full-time
  • Quick Apply
Job description
Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

Overview:

We are seeking a Regulatory Submission Publishing Specialist to join our Diagnostics Regulatory Affairs team. The ideal candidate will manage and facilitate the preparation, submission, and publishing process of regulatory submissions intended for registration
purposes, primarily in the US or EU.


Key Responsibilities:
  • Coordinate the submission and publishing process for regulatory registrations, primarily for the US and EU markets.
  • Prepare submissions in accordance with external health authority guidelines, and internal standard practices.
  • Prepare and format documents according to publication and submission requirements.
  • Liaise with project leads, project teams, and regulatory bodies to gather
  • necessary documents and ensure smooth submission processes.
  • Maintain tracking systems to monitor the status and deadlines of all submissions.
  • Support the management of publication databases and repositories.
  • Collaborate with Regulatory Leads and Managers to ensure submission
  • deliverables meet requirements are fulfilled.

Qualifications:
  • BA in Life Sciences, Regulatory Science, Quality, or related field.
  • Proven experience in preparing compliant regulatory submissions in the diagnostics or pharmaceutical sector.
  • Strong attention to detail and organizational skills.
  • Excellent written and verbal communication skills.
  • Proficiency with industry-standard publishing and submission software and tools.
  • Ability to manage multiple projects and meet deadlines in a fast-paced environment.
  • Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and publication ethics.
  • Minimum years of experience: 5 years
Preferred:
  • Proficiency with industry standard publishing and submission software and tools (Microsoft Word, Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals)
  • Previous experience in a diagnostics, pharmaceutical, or biotech company.
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Regulatory Submission Publishing Specialist • Pleasanton, CA, US

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