Associate Director / Director, Nonclinical Regulatory Affairs

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

Summary

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.

Responsibilities

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.
  
  

Pre-clinical/Nonclinical Regulatory Strategy

• 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.
  
  

KOL and External Expert Engagement

• 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.
  
  

Cross-functional Collaboration

• 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.
  
  

Experience (Required)

• 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.
  
  

Preferred Qualifications

• Working knowledge of pre-clinical/nonclinical pharmacology and/or DMPK.
• Experience in rare diease
• 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 development teams (U.S.–Japan collaboration preferred).
• Experience working with a regulator (FDA/EMA) as a reviewer.
  
  

Education

• Ph.D., Pharm.D., D.V.M., D.A.B.T., M.D., or equivalent degree in toxicology, pharmacology, pharmaceutical sciences, or a related field.
• Typically, 10 years of experience in nonclinical drug development within the pharmaceutical or biotechnology industry, including significant experience in pre-clinical/nonclinical regulatory affairs.
• Experience supporting at least one NDA/BLA and multiple IND/CTA submissions preferred.
• Experience working with a regulator (FDA/EMA) as a reviewer is desired but not necessary
  
  

Compensation And Benefits

NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.

The annualized target salary range for this role is Associate Director: $170,000- $190,000; for Director: $195,000- $210,000 210,000 actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.

Other Benefits Include

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
• Discretionary Bonus Programs and Long-term Incentive Plan
• Retirement Savings 401k with company match
• Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown.
• Career Development, Progression and Training
• Flexible Work Arrangement Programs
  
  

Applications will be accepted until August 31, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma.

NS Pharma is an EEO employer.