Teams at Pulmovant

The Associate Director of Regulatory Affairs supports global regulatory strategy and execution for clinical development and product registration. Responsibilities include preparing and reviewing IND, CTA, BLA, NDA, and MAA submissions; coordinating with health authorities, CROs, and cross-functional teams; managing regulatory deliverables, responses, briefing documents, and compliance activities; monitoring regulatory intelligence; and supporting policies, budgets, and timely submissions across global programs.

Provides quality oversight of contract manufacturers, testing laboratories, packaging vendors, and logistics partners. Leads batch record review, clinical lot disposition, GMP audits, quality systems, deviations, investigations, CAPAs, change controls, and quality agreements. Partners with CMC, Supply Chain, and Regulatory Affairs on product quality risks, inspection readiness, and regulatory submissions. Supports global clinical development and multi-regional compliance in a hands-on biotechnology environment.