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.

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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. ","datePosted":"2025-09-15T13:39:44+00:00","validThrough":"2025-10-30T13:39:44+00:00","employmentType":["Permanent"],"hiringOrganization":{"@type":"Organization","name":"Proclinical","image":"https://www.proclinical.com/img/329befdb-b78c-4661-4cc4-08d71facb4f3","logo":"https://www.proclinical.com/img/329befdb-b78c-4661-4cc4-08d71facb4f3","sameAs":"https://www.proclinical.com","url":"https://www.proclinical.com"},"industry":["Regulatory Affairs"],"jobBenefits":"US$220000.00 - US$265000 per annum + Highly Competitive Salary","identifier":{"@type":"PropertyValue","name":"Proclinical","value":"66979"},"jobLocation":[{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Parsippany-Troy Hills","addressRegion":"USA","addressCountry":"United States"}}]}