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.