Remote Oncology Regulatory Affairs Director - NDA/BLA Expert

Regulatory Connect; United States; Remote; USD 250,000 - 450,000; Full time

Job summary

Regulatory Connect is partnering with an oncology biotech to appoint a Senior Director / Executive Director to lead global regulatory strategy for a new oncology medicine, with a primary focus on US marketing approval through the FDA.

The ideal candidate has led an original NDA/BLA through approval, excels in cross-functional leadership, and can balance strategy with hands‑on delivery across global teams.

Qualifications

• Accountable Regulatory lead for at least one original NDA or BLA from prep to approval.
• Extensive oncology regulatory experience with strong FDA oncology knowledge.
• Experience leading FDA interactions and strategic decision-making during the submission process.
• Post-approval regulatory experience.
• Biotech environment experience with strategic yet hands-on execution.
• Strong communication and cross-functional leadership to coordinate regional teams.

Responsibilities

• Own the US regulatory strategy and lead the original marketing application through submission, FDA review and approval.
• Lead FDA interactions, review responses and regulatory negotiations.
• Develop and execute strategy for complex expedited oncology approval pathways.
• Coordinate global registration activities with regional leads across Europe, Japan and other markets.
• Guide cross-functional teams through submission preparation, review and approval readiness.
• Lead post-approval regulatory activities and support the transition into commercialisation.

Skills

NDA/BLA ownership

Oncology regulatory

FDA interactions

Post-approval regulatory

Cross-functional leadership

Biotech environment

Job description

Regulatory Connect is partnering with an oncology biotech to appoint a Senior Director / Executive Director to lead global regulatory strategy for a new oncology medicine, with a primary focus on US marketing approval through the FDA.

The ideal candidate has led an original NDA/BLA through approval, excels in cross-functional leadership, and can balance strategy with hands‑on delivery across global teams.