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. 

Reports into Regulatory Affairs, Global Filing & Registration 

• High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.

• 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.

• Coordinate NDA Filing and Sub-team rosters for management endorsement.

• Lead cross-functional NDA kickoff according to global filing plans and framework.

• Maintain & track an integrated filing plan including regulatory timelines, modular NDA deliverables, critical path activities, in concert with Regulatory Program Management.

• Identify, respond to, and proactively mitigate risks to NDA timelines or regulatory outcomes and report progress to senior management.

• Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.

• Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.

• Motivate, mentor and develop direct reports to ensure development and performance.

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. 

  #LI-Hybrid  #LI-SH1