Associate Director/Director, Regulatory Operations

Location: Remote (U.S.). Eligibility to work in the United States is required.

Salary: $155,000–$220,000 per year, depending on experience, qualifications, and location.

Company

hirify.global is a clinical-stage oncology biotech developing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program.

What you will do

• Plan, compile, publish, validate, and dispatch INDs, CTAs, amendments, annual reports, DSURs, briefing packages, meeting requests, and future marketing applications for FDA and ex-US authorities.
• Own submission plans, content readiness, publishing windows, QC cycles, dispatch dates, gateway operations, and resolution of technical validation issues.
• Administer the RIMS platform, including access, training, controlled vocabularies, data integrity, reporting, system enhancements, migrations, and releases.
• Maintain the regulatory archive and reconciliation processes across RIMS, the eTMF, CRO records, and submission documentation to support inspections and audits.
• Manage CROs, publishing vendors, regulatory operations vendors, budgets, quality oversight, and delivery standards.
• Improve regulatory operations processes, contribute to submission strategy and regulatory intelligence, and mentor junior staff and contractors.

Requirements

• Bachelor’s degree in life science, information science, or a related field.
• 8+ years of regulatory operations experience in biotech, pharmaceutical, or CRO/vendor environments, including ownership of submissions from planning through dispatch.
• Hands-on expertise with eCTD structure, lifecycle management, validation, INDs and/or CTAs, and US plus at least one ex-US region.
• Experience with electronic publishing tools, FDA and regional gateways, RIMS administration, data integrity, reporting, system releases, and UAT.
• Practical knowledge of 21 CFR Part 11, EU Annex 11, ICH guidelines, GxP documentation, records retention, and archival requirements.
• Vendor management, advanced MS Word and Adobe Acrobat skills, clear cross-functional communication, and interest in using AI and emerging technologies to improve workflows.

Nice to have

• Oncology regulatory operations experience, including expedited pathways, adaptive or basket/umbrella trials, and multi-region CTA submissions.
• Experience supporting NDA, BLA, or MAA submissions, major amendments, inspections, or partner audits.
• RIM configuration experience, eCTD v4.0 readiness, experience in a small or mid-sized company, or RAC certification.

Culture & Benefits

• 100% remote work with a flexible schedule.
• Health, dental, and vision coverage for employees and dependents.
• Flexible time off and generous parental leave.
• Traditional and Roth 401(k).
• Competitive salary and equity in a well-funded, clinical-stage biotech with a remote-first culture.