Director, Regulatory Affairs - Infectious Disease

Position Overview

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. The ideal candidate is proactive, strategic, and comfortable operating with minimal oversight while driving timelines and influencing team direction. 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.

Essential Duties

• 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.
• Direct interactions with FDA and other health authorities; prepare teams, lead discussions, and manage responses to queries.
• Lead cross‑functional regulatory efforts by partnering with nonclinical, CMC, clinical, project management, and external partners/CROs.
• Assess regulatory risks, impacts, and mitigation options; communicate recommendations to internal 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.

Necessary Skills and Abilities

• 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.
• Excellent written and verbal communication skills, including regulatory writing and team communication.
• Strong organizational, planning, and prioritization skills with high attention to detail.
• Ability to manage multiple responsibilities in a fast‑paced, dynamic environment.
• Ability to work independently with minimal oversight while collaborating effectively across functions.
• Ability to travel up to 20%.

Educational Requirements

• Bachelor’s degree in biological sciences, pharmaceutical sciences, or related field; advanced degree preferred.

Experience Requirements

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