Associate Director of Regulatory Affairs

Job Summary

To support nonclinical drug development initiatives, the full-time remote Associate Director of Regulatory Affairs will provide strategic regulatory guidance, develop nonclinical regulatory strategies, and lead the preparation of regulatory submissions while collaborating with cross-functional teams.

Key responsibilities

• Provide strategic regulatory guidance for nonclinical development programs, including pharmacology and toxicology
• Lead the preparation and review of nonclinical sections of regulatory submissions (IND, CTA, NDA/BLA) to ensure compliance
• Collaborate with various teams to translate complex scientific data into regulatory narratives and submission-ready documentation

Required qualifications

• PhD (preferred) or MSc in Pharmacology, Toxicology, Pharmaceutical Sciences, or related discipline
• 8-10+ years of Regulatory Affairs experience focused on nonclinical drug development
• Expertise in nonclinical components of IND/CTA submissions, including toxicology and pharmacology
• Strong understanding of global regulatory frameworks (FDA, EMA, ICH M3, ICH S guidelines)
• Experience in medical writing and preparation of nonclinical regulatory dossiers