Senior Director, Regulatory Strategy – Global Regulatory Lead (Immunology)

Location: Boston, Massachusetts, United States. Hybrid work requires at least two days on-site per week, currently Tuesday and Wednesday; a remote arrangement is also available with periodic travel to the company's offices.

Salary: $242,000–$313,000 USD annually, plus a discretionary annual bonus and potential long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Develop and lead integrated global regulatory strategies for immunology and inflammation pipeline programs from pre-IND planning through post-approval activities.
• Guide development plans, regulatory risk assessment, filing sequencing, and Health Authority engagement across FDA, EMA, PMDA, and other jurisdictions.
• Lead preparation and execution of regulatory meetings, including briefing documents, timelines, agency interactions, and translation of feedback into development recommendations.
• Lead IND, CTA, NDA, BLA, and pediatric development plan submissions while maintaining integrated regulatory development plans and timelines.
• Partner with Clinical Development, CMC, Non-Clinical Sciences, Bioanalytics, and Translational Sciences teams to align development activities with regulatory strategy.
• Contribute to regulatory due diligence, resource planning, budgeting, and development of regulatory infrastructure and best practices.

Requirements

• Advanced degree such as a PhD, PharmD, or master's degree in a relevant life sciences discipline.
• At least 12 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, including 5–7 years leading global regulatory strategy for clinical development programs.
• Deep experience developing regulatory strategies for biologics and/or small-molecule therapeutics across FDA, EMA, and additional global jurisdictions.
• Extensive experience leading FDA pre-IND, Type B, and Type C meetings and EMA Scientific Advice meetings.
• Thorough knowledge of FDA regulations, EMA frameworks, ICH E8(R1), ICH E9(R1), and guidance relevant to early clinical development.
• Strong strategic thinking, communication, leadership, judgment, and ability to translate complex scientific and regulatory information into actionable recommendations.

Nice to have

• Experience in immunology, inflammation, autoimmune disease, or related therapeutic areas.
• Knowledge of the lupus regulatory landscape and precedent regulatory decisions.

Culture & Benefits

• Flexible work arrangements with hybrid and remote options.
• Health and wellness coverage tailored to the country or region of employment.
• Paid time off, public holidays, and additional leave in accordance with local requirements.
• Inclusive environment with equal employment opportunity and reasonable accommodation support.