Regulatory Affairs Lead
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Job Description
The Position
As the most senior member in the team, set strategy and priorities for the team, allocate resources accordingly, provide coaching and mentorship to the team members and represent the team internally and externally or otherwise delegate as appropriate.
Orchestrate and oversee preโlaunch registration strategies and lead the coโcreation of launch readiness in collaboration with respective pods.
Oversee and manage all Regulatory Affairs work of the Affiliate; oversee external parties, such as distributors, agents, etc. if applicable.
Drive continuous process optimization in the Regulatory Affairs area, with an aim to improve efficiency as well as compliance.
Engage Health Authorities, government bodies, as well as pharmaceutical industry associations in shaping regulatory policies and environment towards continuous improvement in addressing unmet medical needs for patients.
All Roche employees are expected to practice high stan...