Junior Regulatory Submission Publisher

CHF60 - CHF65 per hour
  1. Interim/Contract
Basel
  1. Regulatory Affairs, Operations
Posted: 09/03/2020
BBBH13627

This vacancy has now expired. Please see similar roles below...

Hobson Prior are looking for a Junior Regulatory Submission Publisher to a Swiss global healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. You will join them on a contract basis in Basel.

Job Responsibilities:

  • Plans, coordinates, compiles, publishes, and submits regulatory applications, in compliance with health authority regulations worldwide.
  • Partakes in project planning to ensure submission requirements and timing are in alignment with overall project timelines.
  • Partners with more senior staff to work on more complex submission activities.
  • Ensures documents are compliant with company standards, ICH, and other guidelines for incorporation into eCTD submissions using publishing and editing tools.
  • Completes quality assurance/quality control checks to ensure overall submission quality.
  • Develops and maintains knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics.
  • Contributes in development and implementation of new systems, processes, or other relevant tools; e.g., user acceptance testing for publishing system upgrades.
  • Proactively shares best practices within the department and cross-functionally; identifies and communicates opportunities for departmental enhancements and efficiencies.
  • May act as a Subject Matter Expert and/or support an SME for specific RSG activities.

Key Skills:

  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), Adobe Acrobat, regulatory publishing software, and document management systems.
  • Excellent communications and organizational skills.

Requirements:

  • At least one year's experience in regulatory affairs, pharmaceutical or biotech industry, publishing, and/or document management.
  • Associate or bachelor's degree in Life Science or business-related field.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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