Senior Director, Regulatory Affairs

Our client, an innovative and fast-growing biotechnology company advancing next-generation biologics, is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy and operations across their expanding pipeline.

This leader will play a pivotal role in driving IND/CTA submissions, health authority interactions, and cross-functional alignment across Clinical, Preclinical, CMC, and Quality. The ideal candidate brings a proven track record in protein and antibody therapeutics and thrives in a hands-on, entrepreneurial biotech environment.

Key Responsibilities

• Lead the design, preparation, and submission of global regulatory filings (INDs, CTAs, amendments, safety reports, briefing documents, etc.) across preclinical and clinical programs.
• Serve as the regulatory lead on cross-functional project teams, providing strategic guidance and risk assessment throughout development.
• Develop and implement global regulatory strategies to support both preclinical and clinical milestones aligned with corporate objectives.
• Partner closely with Clinical Operations, Preclinical, Quality, and CMC functions to ensure regulatory activities are fully integrated with overall program execution.
• Oversee regulatory communications and meetings with FDA, EMA, MHRA, and other global authorities (e.g., INTERACT, pre-IND, Type C, End-of-Phase 2, Scientific Advice).
• Advise executive leadership on regulatory timelines, pathways, and risk mitigation strategies.
• Build and lead a scalable regulatory function that supports organizational growth and prepares for late-stage submissions.

Qualifications

• Advanced degree (PhD, PharmD, or MS) in a life sciences discipline.
• 10+ years of experience in regulatory affairs within the biopharmaceutical industry, with increasing leadership responsibility.
• Demonstrated success in preclinical and early clinical regulatory submissions (IND, CTA) for biologics or antibody-based therapeutics.
• Strong knowledge of ICH, FDA, and EMA regulations and expectations for preclinical and clinical development.
• Experience in early-stage biotech environments, building and implementing regulatory systems and processes.
• Proven ability to manage global agency interactions and lead cross-functional teams through rapid-growth phases.
• Exceptional written and verbal communication skills; able to influence and guide senior stakeholders.

Preferred Experience

• CMC regulatory experience supporting development-stage biologics.
• Background in immuno-oncology, autoimmune, or metabolic therapeutic areas.
• Experience managing multiple IND/CTA filings and agency interactions simultaneously in a fast-paced, resource-conscious setting.