Executive Director Regulatory Affairs

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

Senior Director / Executive Director, Regulatory Affairs – Oncology

Remote, United States

Regulatory Connect is partnering with an oncology biotech to appoint a senior Regulatory Affairs leader to take overall responsibility for global marketing registration activities, with a particular focus on leading a US marketing application through FDA approval.

This opportunity would suit an established Senior Director or Executive Director who has personally led an original Oncology NDA or BLA through approval and enjoys combining regulatory strategy with hands-on delivery.

The role

You will lead the global registration strategy for a new oncology medicine, working with regional Regulatory leads responsible for parallel applications outside the US.

Responsibilities will include:

• Owning the US regulatory strategy and leading the original marketing application through submission, FDA review and approval.
• Leading FDA interactions, review responses and regulatory negotiations.
• Developing and executing strategy for complex expedited oncology approval pathways.
• Coordinating global registration activities with regional leads across Europe, Japan and other markets.
• Guiding cross-functional teams through submission preparation, review and approval readiness.
• Leading post-approval regulatory activities and supporting the transition into commercialisation.

Your experience

• A demonstrated track record as the accountable Regulatory lead for at least one successful original NDA or BLA, from preparation through approval.
• Substantial oncology experience and a strong understanding of FDA oncology development and approval pathways.
• Experience leading FDA interactions and making strategic decisions throughout the marketing application process.
• Post-approval regulatory experience.
• Experience operating effectively in a biotech environment, with the ability to work strategically and remain close to the detail.
• Strong communication skills and the ability to lead cross-functional teams and coordinate regional Regulatory colleagues.