Position Overview

The Senior Director, Regulatory Affairs for Infectious Disease will serve as the senior Regulatory Lead for Tonix’s assigned infectious disease biologics and vaccine programs, providing strategic leadership from early development through initial product registration. The role will shape global development and regulatory plans, lead health authority strategy and interactions, and integrate regulatory input across clinical, nonclinical, and CMC disciplines. The ideal candidate is a strategic, proactive leader who can independently navigate complex regulatory issues, anticipate regulatory and business needs, influence development strategy, and provide clear recommendations to cross-functional teams and senior leadership.

Key Responsibilities

• Serve as the senior Regulatory Lead for biologics, focused on infectious disease programs, providing strategic regulatory leadership across assigned programs.
• Develop, lead, and execute global regulatory strategies across nonclinical, CMC, clinical development, registration, commercialization, and lifecycle management.
• Lead preparation, authorship, and coordination of regulatory submissions across the product lifecycle, including pre-IND packages, INDs, amendments, briefing documents, marketing applications, supplements, and post-approval submissions.
• Serve as a senior regulatory representative in interactions with FDA and other global health authorities; lead regulatory meetings, negotiations, and responses to complex regulatory issues.
• Provide regulatory leadership for commercial and post-approval activities, including product labeling, promotional considerations, lifecycle management, and implementation of post-marketing commitments and requirements.
• Lead cross-functional regulatory efforts by partnering with nonclinical, CMC, clinical, commercial, medical affairs, project management, and external partners/CROs.
• Anticipate and assess regulatory risks, impacts, and mitigation strategies; provide strategic recommendations to cross-functional teams and senior leadership.
• Ensure compliance with FDA, ICH, and global regulatory requirements, as well as internal SOPs and GxP standards.
• Oversee regulatory documentation quality and timely delivery of program milestones.
• Ability to manage multiple responsibilities in a fast‑paced, dynamic environment.
• Comfortable operating in a fast-paced biopharmaceutical environment, with the ability to roll up your sleeves, work hands-on, and adapt as priorities evolve.
• Ability to travel up to 20%.

Qualifications

• Bachelor’s degree in biological sciences, pharmaceutical sciences, or a related field; an advanced scientific degree is strongly preferred.
• Minimum of 12 years of progressively responsible regulatory affairs experience, including substantial experience leading global regulatory strategy for vaccine or infectious disease development programs.
• Significant regulatory experience with prophylactic or therapeutic vaccines, infectious disease biologics, or closely related products, supported by a strong scientific foundation in immunology, infectious diseases, or related disciplines.
• Experience serving as a Global Regulatory Lead or equivalent accountable regulatory leader for complex development programs.
• Proven experience guiding programs from early development through marketing application preparation or submission, including INDs or CTAs, briefing packages, agency responses, and BLAs or MAAs.
• Demonstrated experience leading FDA interactions, working with other major global health authorities, and translating agency feedback into actionable development plans.
• Experience leading multidisciplinary regulatory teams and influencing cross-functional development and governance decisions.
• Strong knowledge of FDA, ICH, EU, and applicable global regulatory requirements and guidelines.
• Excellent written, verbal, and executive-level communication skills, including regulatory writing and presentation of complex regulatory recommendations.
• Experience mentoring and developing regulatory professionals, with or without direct reporting relationships.
• Strong organizational, planning, and prioritization skills with high attention to detail.