About the job

We are seeking for a Senior Regulatory Affairs Assistant responsible for ensuring the delivery of regulatory activities performed on our regulatory affairs within the Nordic team :

About us

Group 10

  • Execute on global regulatory strategy for established product(s) on continued post-approval product optimization, within relevant regions/countries and in line with the business strategy
  • Lead maintenance activities on established marketing authorisations to ensure regulatory compliance and delivery according to defined milestones and timelines
  • Prepare/contribute preparation of dossiers to support marketing authorization applications in close collaboration with Regulatory Strategy Lead
  • Ensure review of local Product Information before submission
  • Coordinate cross-product activities and strategic effort on regulatory activities as relevant
  • Support preparation of health authority interactions
  • Collaborate and liaise with regulatory affiliates and partners
  • Develop and maintain strong collaboration and communication with main internal stakeholders of Products/projects (Regulatory Strategy Leads, Supply, Global Patient Safety, Commercial Operations and Medical Affairs)
  • Actively support regulatory intelligence, regulations and guidance activities to optimise cross-functional knowledge sharing.  Proactively share knowledge and lessons learned
  • Represent Regulatory in cross functional settings and cross functional working groups as relevant


Group 13

Our preferred candidate has the following qualifications and experience:

  • University credentials in a relevant life science or medical discipline with a few years’ experience working in regulatory affairs
  • Understanding of guidelines/legislation and awareness of global regulatory environment
  • Ability to work structured, independently and effectively across functions and geographies
  • Team player with good interpersonal skills including excellent communication, messaging and presentation skills
  • Fluent in English both written and spoken

Regulatory Affairs Assistant 350