Director, Regulatory Affairs (Global Filing Lead)

Proven success in executing global NDA/MAAs (preparation, submission & 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.

Prior experience with regulatory filings and strategy in APAC and access consortium countries highly preferred.

The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global 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.

Reports into Regulatory Affairs, Global Filing & Registration

High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the EU, UK, Japan and internationally.

Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.

Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.