Regulatory Submission Professional

  • Dublin
  • Permanent
  • JO-1901-64199_1548759625

Summary

Responsibilities

  • Manage and keep an overview of the Regulatory Submission Pipeline for life-cycle submission activities. This includes liaising across regulatory content owners inside and outside RA and our sourcing partner
  • Plan, prepare, and drive the submission strategies
  • Take active part of the regulatory cross-functional focus team within a portfolio representing Submission Management and acting as counterpart to other parts of Regulatory Affairs (RA) working within the same portfolio (e.g. RA CMC, RA Labelling and Regulatory Affairs Project)
  • Monitor progress performance on the Regulatory Submission Plans and communicate goals, status, challenges, opportunities, risks as well as potential solutions to relevant stakeholders
  • Authoring and reviewing Module 1 documentation
  • Coordinating the review of published output
  • Coordinating responses to health authority questions and commitments
  • In close collaboration with sourcing partner, ensuring that regulatory information management system is updated with submissions details, and that documents are uploaded in the document management system according to compliance and quality standards


Requirements:

  • Scientific Master degree, bachelor degree or similar work experience;
  • 2 years or more experience working in Regulatory Affairs within different areas (CMC, Labelling, Clinical, Submission Management, Local RA or similar)
  • Knowledge and preferably experience within Submission Management in relation to submission processes;
  • Understanding of CMC and Labelling components for post-approval activities;
  • Solid project manager skills and experience from project managing regulatory activities/submission pipelines
  • Strong ability to manage a submission pipeline, keep the overview and prioritise; strong drive and ability to execute according to plan).

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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