Regulatory Strategy Lead, Nonclinical Development

Altasciences; Everett (WA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Training & Development Programs

Employee Referral Bonus Program

Job summary

Altasciences in Washington state seeks an Associate Director, Regulatory Affairs – Nonclinical Development to steer regulatory strategy for preclinical programs, ensuring nonclinical data packages support clinical entry and market submissions.

You will partner with sponsors and cross‑functional teams to translate complex data into regulatory plans, guide IND/CTA submissions, and mentor junior staff while advancing diverse modalities.

Qualifications

• PhD (preferred) or MSc in Pharmacology, Toxicology, Pharmaceutical Sciences, or related discipline.
• 8–10+ years of Regulatory Affairs experience with a strong focus on nonclinical drug development.
• Experience supporting IND/CTA submissions and interpretation of nonclinical data for regulatory strategy.

Responsibilities

• Provide strategic regulatory guidance focused on nonclinical development programs.
• Develop and execute nonclinical regulatory strategies to support early‑phase drug development and clinical trial applications.
• Lead the preparation and critical review of nonclinical sections of regulatory submissions (IND, CTA, NDA/BLA).
• Conduct gap analyses of nonclinical data packages, identifying risks and defining mitigation strategies for regulatory success.
• Serve as SME during health authority interactions (INTERACT, pre‑IND, scientific advice).
• Collaborate with Nonclinical, Clinical, Toxicology, Pharmacology, DMPK, and Medical Writing teams to ensure aligned development strategies.
• Translate complex scientific data into clear regulatory narratives and submission‑ready documentation.
• Support business development activities, including proposal strategy, regulatory input, and client consultations.
• Contribute to SOPs and best practices related to nonclinical regulatory science and submissions.
• Mentor and guide junior regulatory professionals.

Skills

Nonclinical regulatory strategy

Medical writing

Regulatory submissions (IND/CTA/NDA/Bi

Cross-functional collaboration

Leadership & mentoring

Education

PhD in Pharmacology/Toxicology/Pharmaceutical Sciences

MSc in related discipline

Job description

Altasciences in Washington state seeks an Associate Director, Regulatory Affairs – Nonclinical Development to steer regulatory strategy for preclinical programs, ensuring nonclinical data packages support clinical entry and market submissions.

You will partner with sponsors and cross‑functional teams to translate complex data into regulatory plans, guide IND/CTA submissions, and mentor junior staff while advancing diverse modalities.