Senior Director, Regulatory Affairs – Infectious Disease

We need to output HTML fragment with sections: About the role? Actually we have Position Overview, Key Responsibilities, Qualifications, Salary Range, Compensation & Benefits. Also maybe "Company Tonix Pharmaceuticals Job Location Berkeley Heights, NJ Salary Range $120k+ Time Type Seniority Senior Level Posted September 22, 2026 Application Deadline October 7, 2026" - but we should not repeat job title as heading; we can include metadata in a short

. The instruction: "Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it." So we can include location, posted date, deadline maybe in a paragraph. We must include sections only when posting has real specific content. We have: - About the role? Could be Position Overview. Use heading

About the role

or maybe "Position Overview". The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should use those exact headings? It says e.g., so we can use those headings. Likely they expect headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have content for About the role (Position Overview), Responsibilities (Key Responsibilities), Qualifications (Qualifications), Benefits (Compensation & Benefits), Pay (Salary Range). No Skills separate; maybe we can omit. No Schedule. We must not create sections with filler like "commensurate with experience". We have actual salary range: $200,000—$275,000 USD. Also earlier there is Salary Range $120k+ but that's likely generic; we should use the specific salary range given later. So Pay section with that. Benefits: list from "Compensation & Benefits" paragraph. We need to remove boilerplate: EEO, etc. Also remove application instructions, recruitment & staffing agencies note, etc. Also remove "Please note that Tonix does not offer sponsorship for this role." That's maybe relevant? It's a note about sponsorship; could be considered minor metadata? Might keep as part of About the role? Probably we can drop as it's not substantive? It's a condition; but maybe we keep as part of About the role? The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." The sponsorship note is substantive? It's a condition of employment. Might keep. However it's not under a specific section; we could incorporate into About the role paragraph. Also "Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes." That's application instruction/boilerplate; we should remove. Also "Apply Now" - remove. Also "To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X." That's maybe boilerplate; could be removed as not substantive? It's company info; maybe keep as part of About the role? Might be considered boilerplate; but it's not a legal/EEO. Might keep as part of About the role? The instruction: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." This is not exactly those; it's just company info. Might keep. But we need to preserve ALL substantive information. The company description is substantive. So we keep that in About the role. Now structure:

Metadata: Location: Berkeley Heights, NJ. Posted: September 22, 2026. Application Deadline: October 7, 2026.

Then sections:

About the role

... (position overview + company description + maybe sponsorship note)

Responsibilities

• ... each responsibility

Qualifications

• ... each qualification

Benefits

• ... each benefit

Pay

Salary Range $200,000—$275,000 USD

We must not include Skills or Schedule. Now we need to extract responsibilities list from "Key Responsibilities". The text is a paragraph with sentences separated by periods. We need to split into list items. Let's parse: "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%." We need to split each sentence into a list item. Some sentences are long but okay. Let's create list items: - 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%. Now qualifications list from "Qualifications". Paragraph: "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." Split into list items: - 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. Now benefits list from "Compensation & Benefits Tonix provides a comprehensive compensation and benefits package which includes: Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance ProgramsPet InsuranceRetirement Savings 401k with company match and annual discretionary stock optionsGenerous Paid Time Off, Sick Time, & Paid HolidaysCareer Development and Training" We need to split items. The text seems to have missing punctuation; we can parse: - Medical, Dental & Vision Insurance - Basic and Voluntary Life and AD&D Insurance - Short- and Long-Term Disability Insurance - Flexible Spending Accounts - Health Savings Account - Employee Assistance Programs - Pet Insurance - Retirement Savings 401k with company match and annual discretionary stock options - Generous Paid Time Off, Sick Time, & Paid Holidays - Career Development and Training Now About the role paragraph: combine company description and position overview. Also maybe include sponsorship note? The note "Please note that Tonix does not offer sponsorship for this role." is a condition; we could include as a sentence in About the role. Let's craft About the role paragraph: "Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch