Director, Regulatory Affairs - Infectious Disease

Strong scientific foundation in immunology, infectious diseases, or related biological disciplines.

Proven experience preparing and submitting INDs and related early‑phase regulatory documents.

Demonstrated ability to independently lead regulatory strategy and cross‑functional teams.

Strong knowledge of FDA, ICH, EU, and applicable global regulatory guidelines.

10–12+ years of progressively responsible regulatory experience with demonstrated program leadership.

Recruitment & Staffing Agencies

The Director, Regulatory Affairs for Infectious Diseases will serve as the primary Regulatory Lead for Tonix’s infectious disease biologics programs.

This role oversees global regulatory strategy, submissions, health authority interactions, and cross‑functional leadership from early development (nonclinical, pre‑IND) through clinical stages.

This position will report directly to the Head of Regulatory Affairs and will be based at a Tonix office or can be a remote-based position.

Serve as Regulatory Lead for biologics, focused on infectious diseases programs.

Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.

Lead preparation, authorship, and coordination of regulatory submissions, including pre‑IND packages, INDs, amendments, and briefing documents.