Regulatory Affairs Lead

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...