Regulatory Strategy Lead (FDA)

Job Overview

The Director, Regulatory Affairs provides senior regulatory and integrated project leadership for global drug development projects, with deep hands‑on expertise in US and EU regulatory strategy and delivery. The role acts as both Regulatory Lead and Project Lead, with direct accountability for authoring and delivering key regulatory submissions and leading cross‑functional development activities, including Indication Prioritization assessment, Target Product Profiles (TPP), and Clinical Development Plans (CDP). Working directly with biopharmaceutical clients, this role serves as a trusted strategic advisor and primary point of contact, integrating regulatory, clinical, safety, CMC, nonclinical, biostatistical, and commercial inputs to drive high‑quality, compliant, and executable development strategies across the product lifecycle, delivered on time, within scope, and within budget.

Essential Functions

• Acts as Project Lead for develo...