Lead Regulatory Project Manager

Location: Remote

Job Type: Permanent/FTE

Position Overview

Key Responsibilities

• 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.
• Provide additional support as required.

Minimum Requirements