Senior Director, Regulatory Science and CMC Development Strategy

Overview

The Senior Director, Regulatory Science and CMC Development Strategy is a senior Regulatory Affairs leader responsible for early-stage CMC regulatory strategy and for providing broad regulatory science expertise across the Celldex portfolio. Reporting to the Vice President, Regulatory Affairs, this individual supports advancement of products from IND through late-stage development and serves as a senior advisor on complex issues spanning Clinical, CMC, Quality, Manufacturing, and Regulatory functions.

The Senior Director partners closely with the Regulatory CMC lead, Manufacturing, and Quality to strengthen development-phase CMC strategy, GMP compliance, inspection readiness, and site training capabilities. The role also contributes to major Health Authority interactions, regulatory risk assessments, cross-functional strategic initiatives, and development of Regulatory Affairs capabilities.

Responsibilities

CMC Development Strategy

• Lead regulatory strategy for early-stage CMC development activities and support advancement of products from IND through late-stage development.
• Develop phase-appropriate CMC regulatory strategies that align manufacturing development activities, regulatory requirements, program objectives, and planned clinical progression.
• Partner with the Regulatory CMC lead to ensure continuity and alignment between early development, registration-stage, and commercial CMC strategies.
• Identify CMC regulatory risks, data gaps, dependencies, and mitigation options and communicate recommendations to Regulatory Affairs leadership and cross-functional teams.
• Support preparation and review of CMC content for INDs, CTAs, briefing packages, technical responses, and other development-stage regulatory submissions.

Manufacturing, Quality, and Site Readiness

• Partner with Manufacturing and Quality to strengthen GMP compliance, inspection readiness, and manufacturing-site training initiatives.
• Provide regulatory perspective on development-phase manufacturing, quality, validation, comparability, and facility-readiness topics, in coordination with the accountable Regulatory CMC lead.
• Develop and deliver regulatory and GMP-focused training as requested to help site personnel understand Health Authority expectations and the connection between site practices and regulatory commitments.
• Support preparation for Health Authority inspections and readiness as requested by identifying regulatory risks, clarifying expectations, and helping teams address gaps.

Regulatory Science and Health Authority Support

• Provide regulatory science expertise supporting Health Authority interactions, regulatory risk assessments, and development of regulatory strategy across the portfolio.
• Support major regulatory milestones and Health Authority interactions through issue assessment, precedent analysis, briefing document input, meeting preparation, and strategic advice.
• Evaluate evolving regulations, guidance, policy, and regulatory precedents and translate relevant implications into practical recommendations for Celldex programs.
• Serve as a senior advisor on complex regulatory issues spanning Clinical, CMC, Quality, Manufacturing, and Commercial functions.
• Contribute to development of Regulatory Affairs capabilities through mentoring, training, and sharing of regulatory science expertise across the organization.

Qualifications

• Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent) in a relevant scientific discipline.
• Extensive progressive Regulatory Affairs or regulatory science experience within the biotechnology or pharmaceutical industry, including substantial CMC experience supporting clinical-stage development.
• Demonstrated experience developing phase-appropriate CMC regulatory strategies and supporting products from IND through later-stage development.
• Experience supporting FDA and/or global Health Authority interactions, briefing documents, regulatory risk assessments, and responses to technical questions.
• Working knowledge of GMP expectations, manufacturing and quality systems, and inspection-readiness principles.
• Demonstrated ability to advise senior leaders, influence cross-functional teams, communicate complex scientific issues clearly, and mentor colleagues.

Preferred

• Experience with biologics, monoclonal antibodies, combination products, or manufacturing-site regulatory readiness.
• Experience designing or delivering GMP and regulatory training for manufacturing or Quality personnel.
• Experience spanning multiple regulatory disciplines, such as Clinical, CMC, Quality, regulatory intelligence, policy, or commercial-stage support.
• Experience working in a small or growing biotechnology company and supporting multiple programs or high-priority strategic initiatives.

Compensation Statement