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Regulatory Affairs Lead

F. Hoffmann-La Roche AG | subang jaya, Malaysia | Posted June 12, 2026

Position Overview

Responsibilities and Accountabilities

  • Set strategy and priorities for the senior regulatory affairs team, allocate resources, provide coaching, and represent the team.
  • Orchestrate and oversee pre‑launch registration strategies and lead co‑creation of launch readiness in collaboration with relevant pods.
  • Oversee all Regulatory Affairs work of the Affiliate, including external parties such as distributors and agents.
  • Drive continuous process optimization in the Regulatory Affairs area to improve efficiency and compliance.
  • Engage health authorities, government bodies, and industry associations to shape regulatory policies and environments.
  • Ensure adherence to Roche’s compliance standards, participate in SHE initiatives, and uphold high fiduciary standards.
  • Develop and implement innovative, risk‑based regulatory strategies for all affiliate products and lead global/regional strategies.
  • Lead strategic oversig...

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