Sr Manager, Regulatory Affairs

Description

Essential Duties and Responsibilities include the following:

As an individual contributor, the Senior Manager will:

· Lead and own the development, execution and oversight of local regulatory strategies for registered products and pipeline assets, ensuring alignment with global and regional regulatory objectives.

· Provide strategic and tactical regulatory advice to internal stakeholders to enable timely and compliant product registration, variations, line extensions, labeling changes, renewals and other lifecycle management activities.

· Act as regulatory lead for complex submissions and initiatives, ensuring end‑to‑end accountability for regulatory outcomes and deliverables in Brazil.

· Serve as a regulatory interface with ANVISA and other relevant external stakeholders, leading health authority interactions, negotiations and regulatory discussions, in alignment with Gilead poli...