Global Regulatory Submission Publisher

Basel, Switzerland

Posted:13 days ago
Location:Basel, Switzerland
Job Ref:BH-33795
Job Type:Contract
Expiry date:12/6/2022
Contact:Callum Costello
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 
  • 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

Apply now