Teams at Alkermes

Lead global regulatory strategy for clinical-stage programs, author and coordinate IND/CTA submissions, advise cross-functional teams, manage submission timelines and risks, respond to regulatory authority questions, and monitor regulatory policy and competitive landscape to support product development and registration.

Lead late-stage small-molecule drug product process development, scale-up and technical transfer (Phase 3 to PPQ). Provide technical oversight at internal and external manufacturing sites, design experiments, develop control strategies, author regulatory process sections, present data to senior management, mentor junior staff, and identify new process technologies.

Provide high-level administrative support to the VP of Commercial Operations and leadership team: manage complex calendars, travel, expense reports, contract routing, meeting logistics, onboarding coordination, records and document management, and lead departmental projects and events in a hybrid (60% on-site) environment.