Position: Mid-Senior level

Job type: Contract

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Job content

This is an exciting contract opportunity in Basel for a top 10 Pharmaceutical company who seek a Global Regulatory Submission Publisher.This role can offer some remote working.The Role
  • Responsible for electronically preparing, publishing, quality reviews, and validation activities related to regulatory submissions
  • Produce high quality, HA compliant submission
  • Partners with Operations Submission Managers and a publishing team
  • Comply with and actively apply internal work practices and guidelines.
  • Support implementation of new technologies, tools and processes.
  • Identify process or technical issues and propose solutions
Requirements:
  • 5-8 years submission publishing experience in Pharma or related industry
  • Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
  • Effective interpersonal skills, strong written and oral communication and presentation skills.
  • Project management and time management skills to manage multiple ongoing projects simultaneously.
  • Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
  • Working knowledge of regulatory affairs
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Deadline: 04-05-2024

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