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.
The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA regulations, current Health Authority thinking, and have strong leadership & problem-solving ability.
Required Skills, Experience and Education
Degree in life sciences, pharmacy, medicine, or related fields with a 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.