Associate Regulatory Operations Director (Biotech)

Location: Alameda, California, United States. Approximately 20% travel required.

Base salary: $157,500–$222,500 annually, adjusted according to geographic market, skills, experience, and internal equity.

Company

hirify.global is a biotechnology company developing and commercializing medicines.

What you will do

• Oversee planning and execution of electronic regulatory submissions, including INDs, NDAs, BLAs, and supplemental applications.
• Manage the submission forecast, staffing plans, timelines, deliverables, roles, risks, and status reporting.
• Lead cross-functional initiatives focused on submission process optimization and operational effectiveness.
• Develop submission planning best practices and support departmental ways of working.
• Provide guidance on Veeva RIM and identify IT solutions for regulatory operations systems.
• Contribute to SOPs, work instructions, internal guidelines, and mentoring for the Regulatory Operations team.

Requirements

• Bachelor’s degree with at least 11 years of related experience, or a master’s degree with at least 9 years, or a PhD with at least 5 years; equivalent combinations may be considered.
• In-depth knowledge of global regulatory submission requirements, regulatory frameworks, and industry practices.
• Experience managing complex plans, multiple activities, timelines, deliverables, and task-related risks.
• Strong written and verbal communication, presentation, interpersonal, problem-solving, and stakeholder collaboration skills.
• Ability to lead teams and build productive cross-functional relationships; no direct supervisory responsibilities.

Culture & Benefits

• Collaborative office environment focused on sharing ideas and solutions.
• Equipment includes dual monitors and ergonomic chairs.
• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• 401(k) plan with company contributions, stock purchase opportunities, and long-term incentives.
• Fifteen accrued vacation days in the first year, 17 paid holidays including a winter shutdown, and up to 10 sick days annually.
• Eligibility for a discretionary annual bonus program.