Head of Regulatory CMC Strategy (Biosimilars)

Head of Regulatory CMC Strategy (Biosimilars)

Senior Director / Executive Director | Hybrid (U.S.)

About the Company

An AI-native biopharmaceutical company focused on expanding access to biosimilar medicines across the Americas. Operating with a hyper-lean, fully outsourced model, the organization leverages purpose-built technology and strategic CDMO partnerships to accelerate development.

Fully funded and backed by a dedicated biotech investment platform, the company is advancing a pipeline of 12+ programs across oncology, immunology, and cardiometabolic disease, with initial product launches expected in 2025.

As part of a strategic U.S. expansion, the company is leveraging the FDA's streamlined biosimilar pathway to bring monoclonal antibody programs to market more efficiently and cost-effectively. This role is foundational to that effort.

Why This Opportunity

Founding leadership impact
Shape regulatory strategy and development frameworks from the ground up with direct access to executive leadership.

AI-native operating model
Work within a company built around advanced tools, automation, and modern development infrastructure.

Capital stability
Fully funded with long-term financial backing-no reliance on near-term fundraising.

Established foundation
Pipeline, regulatory infrastructure, and QMS already in place, with near-term product launches.

The Role

This is a strategic Regulatory CMC leadership role, not a traditional bench-based position.

With a fully outsourced development model, this individual will define regulatory strategy, design development pathways aligned with FDA expectations, and direct CDMO partners to deliver against those plans. The focus is on regulatory insight, program design, and execution oversight.

Key Responsibilities

Regulatory Strategy & FDA Leadership

• Own end-to-end Regulatory CMC strategy for biosimilar programs (351(k) pathway)
• Lead FDA interactions, including Type A/B meetings
• Author and oversee CMC sections of IND and BLA submissions
• Develop analytical similarity strategies to support clinical efficacy waivers

Program Design & Development Execution

• Define regulatory requirements and development sequencing based on FDA expectations
• Build streamlined development blueprints to accelerate timelines and reduce cost
• Guide external partners in executing against program strategy

CDMO & Partner Oversight

• Manage CDMO relationships and ensure delivery against regulatory milestones
• Evaluate externally generated data for quality and submission readiness
• Operate effectively in a fully outsourced development model

Pipeline & Business Development Support

• Assess pipeline assets and in-licensing opportunities through a regulatory lens
• Evaluate feasibility and development requirements under streamlined pathways

Cross-Functional Leadership

• Partner with Regulatory Affairs and executive leadership on overall strategy
• Contribute to company-building efforts, culture, and operating model

Ideal Candidate Profile

• Deep expertise in biosimilar regulatory pathways, including 351(k)
• Experience in Regulatory CMC, program leadership, or alliance management
• Strong track record of IND/BLA authorship and FDA interactions
• Experience working with CDMOs and outsourced development models
• Background in monoclonal antibodies or complex biologics preferred
• Startup or lean biotech experience strongly preferred
• Builder mindset with comfort operating in high-ownership, fast-paced environments
• Strong strategic thinking with the ability to translate regulatory requirements into executable plans

Compensation & Benefits

• Competitive base salary and performance-based incentives
• Equity participation
• Comprehensive benefits package
• Flexible hybrid work model

Equal Opportunity & Employment Disclaimers

This organization is an equal opportunity employer and is committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Employment is contingent upon successful completion of background checks and verification of eligibility to work in the United States.