Senior Director, Regulatory Clinical Strategy

Senior Director, Regulatory Affairs :

We're hiring a senior regulatory leader to own clinical stage strategy across multiple programs. You'll turn study plans into clear regulatory pathways, lead high-stakes agency interactions, and set an execution rhythm that moves programs-not paperwork.

What you'll do:

• Architect global pathways from FIH through registration (IND/CTA, Type B/C/EOP2, NDA/BLA/MAA), aligning science, risk, and timelines.
• Lead health-authority strategy & meetings (FDA/EMA/MHRA/PMDA, etc.): objectives, scenarios, briefing books, rehearsals, minutes, and follow-through.
• Set submission strategy & bar for quality across authoring, data readiness, and eCTD modules; manage external writers/publishers where needed.
• Drive cross-functional execution with Clinical Development, Biostats, Safety, CMC, Quality, and Program Management; unblock issues before they become delays.
• Leverage expedited pathways (e.g., Breakthrough, Fast Track, PRIME, ILAP, RMAT where applicable) and guide global alignment plans.
• Mentor and elevate a high-performing team; develop playbooks, templates, and ways of working that scale.
• Influence portfolio decisions with crisp regulatory risk-benefit frames, scenario planning, and milestone forecasting.

What you bring:

• ~12+ years in Regulatory Affairs with deep clinical-stage leadership; track record leading agency meetings and delivering major submissions end-to-end.
• Strength in authoring strategy (briefing packages, Module 2, labeling strategy) and orchestration (owners, dates, dependencies, KPIs).
• Comfortable translating clinical and CMC realities into regulatory-savvy trade-offs and executive-ready recommendations.
• Builder's mindset: decisive, data-literate, calm under time pressure, and excellent at narrative-making the complex simple.

Where you'll work & how you'll win:

• Hybrid, New Jersey (regular on-site collaboration with flexibility).
• Success in 90 days: clear pathway reviews for active programs, meeting calendars locked, submission plans baselined.
• Success in 6-12 months: agency meetings delivered cleanly, submissions out on time, risks surfaced early, team operating to a common cadence.

Intrigued? Send your resume to n.walker@proclinical.com or ask for a brief, confidential conversation.