Senior Director, Regulatory Clinical Strategy job in Parsippany-Troy Hills, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Senior/Director & VP, Consultant / Specialist

Location: United States

This vacancy has now expired. Please see similar roles below...

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.