MEET have partnered with one of our cutting-edge biotech clients focused in the autoimmune space to bring on a Senior Director of Regulatory Affairs strategy to their wonderful team.

Responsibilities:

• Lead regulatory strategy for early-stage biologics, including monoclonal antibodies, Fc fusion proteins, and multi-specific antibody formats.
• Define and communicate regulatory best practices across the development lifecycle, including orphan drug designation, indication sequencing, accelerated pathways, and pediatric study planning (PSP/PIP).
• Provide strategic regulatory guidance for nonclinical development and IND/CTA-enabling studies, ensuring alignment with global regulatory standards.
• Manage the transition of regulatory ownership to Otsuka partners post–Proof of Concept, delivering high-quality INDs/CTAs to support risk-mitigated BLA submissions.
• Serve as a strategic regulatory partner to Clinical Operations, Translational Medicine, Nonclinical, CMC, Quality, and Business Development teams, integrating regulatory input early in development decisions.
• Define and lead phase-appropriate CMC regulatory strategy for biologics, including risk mitigation planning and smooth transition from discovery to early clinical development.
• Monitor evolving regulatory requirements and emerging guidance for biologics, antibody-drug conjugates, and combination products.

Knowledge & Experience:

• Possess an advanced degree in a relevant field (PhD, PharmD, MS, or equivalent), with preferred regulatory experience in immunology and/or nephrology.
• Bring 15+ years of global regulatory affairs experience, including 5–7 years in biologics, with deep expertise in early-stage development (IND-enabling, FIH, PoC), CMC regulatory strategy, and global compliance.
• Demonstrate strong knowledge of FDA, EMA, PMDA, and ICH requirements, with a proven track record in developing regulatory strategies and authoring M3 (CMC) sections for INDs and CTAs.
• Exhibit leadership in clinical study design, mentoring regulatory professionals, and driving cross-functional collaboration in a matrixed, global environment.
• Excel in stakeholder management, negotiation, and aligning global regulatory priorities across parent and affiliate organizations.