Jobs at Pulmovant

Manages Pulmovant’s enterprise application portfolio, including validated GxP and clinical systems and core IT platforms. Oversees system performance, configuration, compliance, access, documentation, integrations, upgrades, and validation. Partners with Clinical, Regulatory, Quality, Finance, and HR stakeholders, manages vendors and an applications team, and leads continuous improvement, root-cause analysis, and application initiatives. The role also supports AI and machine learning governance, model validation, and responsible data practices.

Leads global clinical supply planning and execution, including investigational product packaging, labeling, inventory, forecasting, logistics, distribution, vendor management, and regulatory compliance. Oversees contract manufacturers, mentors clinical supply managers, develops procedures and pharmacy manuals, supports submissions and inspections, and manages supply-related risks and business continuity for clinical trials.

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.