Posted to MedZilla on 1/24/2020

Phaidon International

US-MA, Global Regulatory Lead (Director-Level) 452431241683-MZ


Global Regulatory Lead Oncology Or Immunology

  • Work as the US head for the development and implantation of Regulatory Strategy across US Brands
  • Together with Global Regulatory Head, coordinate with Health Authority and regulatory advisory board meetings to support the project and its associated submissions
  • Serve as the US Regulatory expert to sub-committees and teams. Work closely with global health authorities and regulatory teams.
  • Ensure an understanding of the external regulatory competitive environment to adapt product regulatory strategy accordingly
  • ·         Provide an assessment of regulatory opportunities to potentially enhance the development pathway and of regulatory risks for the various options for regulatory development, as well as potential measures for risk mitigation
  • This role is taken by regulatory experts who have regional responsibilities in a defined therapeutic area and have a position reporting to a Therapeutic Area Head
  • Ensure an understanding of the external regulatory competitive environment globally in order to adapt product regulatory strategy accordingly.
  • Ensure top quality across all regulatory submissions.
  • Plan for production of dossier(s) with the required content and quality to support the proposed label and product approval.  The regional lead provides strategic oversight to the submission project manager and RISM on dossier content.
  • Involve R&D QA in the development of project operational plans.

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