Director, Regulatory Affairs (US Filing Lead)
About the position 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.
Responsibilities
- Driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs
- 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
- Support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice
- 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
Requirements
- 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.
Nice-to-haves
- An advanced degree is desirable.
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