Need for Strategic regulatory guidance and tactical support to further the progress of asset regulatory approval, including guiding direction of FDA communication and responses, submission strategy, health authority Q&A, Advisory Committee and other FDA meetings.  Small, Northeast US small drug sponsor, main asset indication:  treatment resistant UTI.  Timelines:   Phase 3 is currently enrolling, expected study completion q1/2 2024, NDA filed Q3/4 2024.

Anticipated hours and duration:

• 20 hours a week (or more, if consultant has available) through 2024.

Regulatory Affairs and Strategy Focus areas:

Must-have Regulatory Experience:

• Strong regulatory/clinical:  Highest concern is around clinical approach and dialog with FDA, as that seems to be FDA’s main area of interest.  Critical to ensure the successful address and management of regulatory issues, dialog, Q&A, negotiation, strategy, inspection readiness, etc., through approval.
• US/FDA experience:  US focused project, however EU/ROW a nice to have as one US approval received focus will turn to other markets (possibly before US approval).
• Late stage experience:  demonstrated experience bringing an asset from Phase 3 over the approval line.
• Pediatric regulatory expertise:  The need for additional study/s around pediatrics has been identified by FDA, so experience in this area of very high value.
• Can work independently.

Nice-to-have Regulatory Experience:

• Reg CMC nice to have but not critical- the manufacturing pathway has made significant progress and not much additional anticipated there.
• PV is being mostly handled by CRO however oversight input required.
• Labeling- always a priority however much progress has been made here as well, anticipated that not too much will need to be done.
• Direct experience with the Division of Immunology is appreciated.
• Within driving distance of northeast CT a very nice to have but remote is OK too.  Some travel (quarterly, or 1-2x per year) to HQ will likely be required.

Tactical needs:

• In terms of tactical NDA support, sponsor has a full regulatory operations group that will be primarily responsible for hands on submission preparation, however increased regulatory strategy (up to full time/40 hours a week) for more focused strategy and submission-intensive attention anticipated during submission time (last 2 quarters of 2024).
• That said, regulatory strategist will have no direct reports so in addition to strategy advisory will be hands on as well.  Example- updating the IB will likely be a task for the Regulatory Strategist.