Associate Director​/Director, Nonclinical Regulatory Affairs

Summary

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We’re exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan

Nonclinical Regulatory Affairs serves as the nonclinical regulatory lead with primary accountability for FDA and EMA interactions, leading and executing regulatory activities across global development stages, including IND-enabling, clinical development, and registration phases.

This role is highly regulator-facing and requires the ability to engage directly, credibly, and scientifically with FDA and EMA reviewers on pre-clinical/nonclinical topics, including complex and high‑risk regulatory issues. The role coordinates the development of pre-clinical/nonclinical regulatory documentation and responses associated with Health Authority interactions and ensures alignment of scientific positions across submissions.

The Associate Director/Director serves as a key interface between nonclinical functions, global regulatory teams, and external experts (including KOLs), ensuring scientifically sound, risk‑based, and regulatorily aligned nonclinical evidence generation strategies that support efficient global drug development.

This is a hybrid role that requires two days in the Paramus, NJ office.

• Health Authority Interactions
• Act as the regulatory subject matter expert for FDA and EMA especially for pre-clinical/nonclinical matters, working in close alignment with global regulatory leadership.
• Lead and coordinate nonclinical regulatory interactions, including Pre‑IND, Type A/B/C, IND/CTA, and NDA/BLA meetings, covering meeting strategy, material review/preparation, internal alignment, and submission logistics.
• Define, articulate, and defend regulator-facing pre-clinical/nonclinical positions, including scientific rationales and risk‑based justifications.
• Provide content and review pre-clinical/nonclinical briefing documents and written responses to FDA and EMA, including clinical hold and major safety‑related questions, and ensure timely fulfillment of meeting follow‑up commitments.

• Develop and execute global pre-clinical/nonclinical regulatory strategies across development stages in alignment with program objectives and applicable regulatory guidance.
• Provide scientifically sound, risk‑based interpretation and justification of nonclinical study findings to support regulatory decision‑making, aligned with ICH guidelines.

• Participate in and support KOL and external expert engagements related to nonclinical safety, toxicology, and translational risk.
• Integrate external scientific input into regulator‑facing pre-clinical/nonclinical strategies and regulatory documentation.

• Collaborate closely with nonclinical safety, pharmacology, DMPK, clinical development, and CMC teams to ensure alignment of nonclinical regulatory positions across key submissions and regulatory communications.
• Serve as a key regulatory interface across U.S., EU, and Japan‑based R&D organizations, enabling global alignment while supporting regional regulatory requirements.

• Strong background in nonclinical safety (toxicology) within pharmaceutical or biotechnology drug development.
• Significant experience with early-stage programs from preclinical to phase 1/2 development
• Hands‑on experience leading or co‑leading FDA interactions from a nonclinical regulatory perspective.
• Experience preparing regulator‑facing briefing documents and written responses.
• Experience supporting or leading KOL and external expert discussions related to nonclinical safety.
• Solid understanding of GLP toxicology studies and their regulatory application.

• Working knowledge of pre-clinical/nonclinical pharmacology and/or DMPK.
• Experience in rare disease preferred but not required
• Experience with FDA clinical hold responses and/or complex EMA safety discussions.
• Familiarity with ICH M3(R2) and ICH S‑series guidelines.
• Experience in rare disease and/or oncology drug development.
• Experience working in global…