Global Regulatory Strategy Lead – Oncology

Alpha-9 Oncology; Boston (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

20 vacation days

5 sick days

Technology allowance

Commuter reimbursement

Extended health benefits

Paid holidays

Job summary

Alpha-9 Oncology seeks an experienced Associate Director, Regulatory Affairs to lead global regulatory strategy and submission planning across our clinical pipeline. Reporting to the Vice President, Regulatory Affairs, this hands‑on role helps shape strategy and execute submissions while supporting health authority interactions across programs.

The ideal candidate brings strong global regulatory knowledge, sound judgment, and a collaborative approach.

Qualifications

• Advanced degree in a scientific, pharmacy, or related discipline and 8+ years of regulatory affairs experience.
• Experience supporting global drug development programs with INDs, CTAs, and other submissions.
• Strong knowledge of FDA, ICH, EU regulations and health authority interactions.

Responsibilities

• Plan and manage regulatory activities across clinical development programs including CMC, nonclinical and clinical.
• Develop and implement regulatory strategies to enable timely approvals globally.
• Lead preparation, review, and submission of regulatory materials (INDs, amendments, CTAs, annual reports, safety reports).
• Coordinate health authority interactions and maintain submission plans and timelines.
• Ensure regulatory records are compliant and inspection-ready.

Skills

Regulatory strategy

Global submissions

Cross-functional leadership

Regulatory intelligence

Project management

Communication

Independent ownership

Education

Advanced degree in a scientific field

Tools

eCTD submissions

Job description

Alpha-9 Oncology seeks an experienced Associate Director, Regulatory Affairs to lead global regulatory strategy and submission planning across our clinical pipeline. Reporting to the Vice President, Regulatory Affairs, this hands‑on role helps shape strategy and execute submissions while supporting health authority interactions across programs.

The ideal candidate brings strong global regulatory knowledge, sound judgment, and a collaborative approach.