Partner with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for high‑complexity programs/products are established and executed seamlessly.
Expertly lead cross‑functional project submission working groups (SWGs) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for complex, novel, and critical programs.
Provide expert project management leadership, oversight, direction, and planning.
Directly support the program GRL by ensuring project management and regulatory operational support for the asset.
Perform regulatory operational activities and oversee vendors providing operational support for assigned programs.