BA/BS degree in a scientific, engineering, or healthcare discipline required
Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management.
Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities.
Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations.
Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization, while maintaining alignment to strategic priorities.
Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy.
Demonstrated ability to leverage project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams.
Demonstrated experience facilitating cross-functional team meetings, driving structured agendas, documenting decisions and actions, and maintaining strong meeting hygiene and team accountability in a matrixed environment.
Expert skills required for Smartsheet and Microsoft Office Suite
Expert in creating visuals using PPT generated from timeline integration tools (ie, One Pager, Office Timeline Pro, etc.)
Proficient user of Veeva Regulatory Information Management (RIM)
