Senior Director, Regulatory Affairs – Infectious Disease (Biologics)

Location: Berkeley Heights, New Jersey or Frederick, Maryland, United States. Ability to travel up to 20%.

Salary: $200,000–$275,000 USD annually.

Company

hirify.global is a commercial-stage biotechnology company developing CNS and immunology treatments, including infectious disease biologics, vaccines, and other products for areas of high unmet medical need.

What you will do

• Lead regulatory strategy for infectious disease biologics and vaccine programs from early development through registration, commercialization, and lifecycle management.
• Develop and coordinate submissions including pre-IND packages, INDs, amendments, briefing documents, marketing applications, supplements, and post-approval submissions.
• Represent the programs in FDA and global health authority meetings, negotiations, and responses to complex regulatory issues.
• Integrate regulatory strategy across clinical, nonclinical, CMC, commercial, medical affairs, project management, and external CRO functions.
• Assess regulatory risks and mitigation strategies while advising cross-functional teams and senior leadership.
• Oversee documentation quality, milestone delivery, labeling, promotional considerations, and post-marketing commitments.

Requirements

• Bachelor’s degree in biological sciences, pharmaceutical sciences, or a related field; an advanced scientific degree is strongly preferred.
• At least 12 years of progressively responsible regulatory affairs experience, including global regulatory strategy for vaccine or infectious disease development programs.
• Substantial experience with prophylactic or therapeutic vaccines, infectious disease biologics, immunology, or related scientific disciplines.
• Experience leading complex programs through INDs or CTAs, briefing packages, agency responses, and BLAs or MAAs.
• Experience leading FDA interactions and working with other major global health authorities.
• Strong knowledge of FDA, ICH, EU, and global regulatory requirements, plus excellent regulatory writing, communication, organizational, and leadership skills.

Culture & Benefits

• Fast-paced, dynamic biopharmaceutical environment with hands-on work and evolving priorities.
• Medical, dental, vision, life, disability, flexible spending, health savings, and employee assistance benefits.
• Pet insurance and a 401(k) retirement plan with company matching.
• Annual discretionary stock options, paid time off, sick time, and paid holidays.
• Career development and training opportunities.