Director, Regulatory Affairs (US Filing Lead)
The Opportunity
The Director of Regulatory Affairs (US Filing Lead) is accountable for driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.
The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice.
Required Skills, Experience and Education
Minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Proven success in executing US NDAs (preparation, submission & approval).
Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.
Demonstrated ability to lead Health Authority interactions and negotiations.
In-depth knowledge of CTD structure and management of dossier components.
Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.
Flexibility to support business needs of dynamic registrational programs.
Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.
Preferred Skills
An advanced degree is desirable.
Pay & Benefits
Base Pay Salary Range $211,000 - $264,000 USD
Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.