Associate Director, Regulatory Strategy (Oncology)

Location: Boston, Massachusetts, USA

Company

hirify.global is a clinical-stage biotechnology company developing radiopharmaceuticals for targeted radiation delivery to solid tumors.

What you will do

• Plan and manage regulatory activities across clinical development programs, including clinical, nonclinical, and CMC work.
• Develop and execute global regulatory strategies supporting efficient development and timely approvals.
• Lead regulatory submission planning, preparation, review, and delivery for INDs, amendments, CTAs, annual reports, safety reports, and related materials.
• Support health authority interactions, including meeting requests, briefing packages, agency responses, and regulatory correspondence.
• Represent Regulatory Affairs on cross-functional teams and provide guidance to Clinical, CMC, Nonclinical, and other functions.
• Build scalable, compliant, inspection-ready regulatory operations, systems, and workflows.

Requirements

• Advanced degree in a scientific, pharmacy, or related discipline.
• 8+ years of regulatory affairs experience in the biopharmaceutical industry.
• Hands-on experience with global drug development programs and clinical-stage submissions, including INDs, amendments, and CTAs.
• Experience developing regulatory strategies and working directly with health authorities in the US and international markets.
• Strong understanding of FDA, ICH, EU, and other global regulatory requirements.
• Excellent communication, organization, attention to detail, ownership, and cross-functional collaboration skills.

Culture & Benefits

• Competitive salary, bonus, and equity.
• 20 vacation days, 5 sick days, and paid holidays.
• Technology allowance and commuter reimbursement.
• Retirement savings plans with employer matching and extended health benefits.
• Inclusive, diverse, and equal-opportunity workplace with reasonable accommodation support.