Oncology Regulatory Strategy Lead (Phase 1–2)

Planet Pharma; Cambridge (MA); Hybrid; USD 160,000 - 210,000; Full time

Job summary

Planet Pharma is seeking a hands-on Regulatory Affairs leader to drive strategy and execution for a growing oncology pipeline. You will lead INDs, CTAs, amendments, and other submissions, collaborating with Clinical Development, CMC, Quality, and external partners to advance programs through Phase 1 and Phase 2 in the U.S., EU, and UK.

This role requires strategic thinking and practical leadership to build Regulatory Affairs capabilities as the pipeline expands, reporting to the Chief Medical

Qualifications

• Significant Regulatory Affairs experience in biotech/pharma.
• Experience leading Phase 1/2 oncology programs.
• Demonstrated U.S. IND and FDA interaction experience.
• Strong knowledge of EU CTAs/CTIS and UK/MHRA regulatory space.

Responsibilities

• Develop and execute regulatory strategy for Phase 1/2 oncology programs.
• Lead INDs, CTAs, amendments, and other regulatory submissions.
• Coordinate interactions with FDA and international health authorities.
• Support clinical development in the U.S., EU, and UK.
• Guide protocols, development plans, and CMC changes from a regulatory perspective.
• Manage external regulatory consultants and vendors as needed.

Skills

Regulatory strategy

INDs

FDA interactions

EU CTAs/CTIS

UK/MHRA experience

Phase 1/2 oncology

Cross-functional collaboration

Job description

Planet Pharma is seeking a hands-on Regulatory Affairs leader to drive strategy and execution for a growing oncology pipeline. You will lead INDs, CTAs, amendments, and other submissions, collaborating with Clinical Development, CMC, Quality, and external partners to advance programs through Phase 1 and Phase 2 in the U.S., EU, and UK.

This role requires strategic thinking and practical leadership to build Regulatory Affairs capabilities as the pipeline expands, reporting to the Chief Medical