Director of Regulatory Affairs
Regulatory Affairs professional with 5+ years of experience in drug development with an emphasis on global strategy, project management, and regulatory operations. Experience developing global regulatory strategies, effectively utilizing expedited and accelerated pathways, as well as leading regulatory authority interactions to enable clinical trials that lead to marketing approvals. Excellence and efficiency in Phase 1-4 regulatory submission activities including strategic common technical document development; facilitation of regulatory interactions; and publishing and submission of Pre-IND submissions through marketing application authorizations and post-marketing activities.
Bachelor’s degree and experience with aerosol delivery, medical device, and 505(b)(2)
Required Relocation Required
Top Reasons to Work for Us
Competitive Salary • Company pays 100%of health insurance • Stock option grants
Help build life changing technology
Pneuma is a pharmaceutical company with advanced aerosol technology that creates breakthrough pulmonary drug delivery solutions. Pneuma’s world class capabilities, partnerships and bold vision create new approaches that dramatically improve the existing standard of care and innovates new-to-world interventions that positively impact the health and well-being of our global community.