Lead, Global Regulatory Strategy – Hematology/Oncology

Scorpion Therapeutics; Princeton (NJ); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Scorpion Therapeutics seeks an Associate Director, Global Regulatory Strategy in Hematology/Oncology to lead regulatory development and lifecycle management for oncology therapeutics.

You will develop global and US regulatory strategies, manage IND/NDAs submissions, ensure dossier quality and compliance, and coordinate cross-functional teams while interfacing with the FDA and other health authorities. This role emphasizes hematology/oncology focus and lifecycle activities.

Qualifications

• PhD, MD, PharmD, or equivalent with regulatory experience.
• 4-8 years in pharma with significant regulatory affairs experience.
• Strong knowledge of IND/NDA processes.

Responsibilities

• Develop global and US regulatory strategies.
• Oversee submission of INDs, BLAs, NDAs, and supplements.
• Ensure quality and compliance in dossiers.
• Manage cross-functional contributions.
• Write and review regulatory documents.
• Lead interactions with FDA and other health authorities.

Skills

Regulatory strategy

IND/NDA processes

Cross-functional leadership

FDA interactions

Education

PhD/MD/PharmD or equivalent

Job description

Scorpion Therapeutics seeks an Associate Director, Global Regulatory Strategy in Hematology/Oncology to lead regulatory development and lifecycle management for oncology therapeutics.

You will develop global and US regulatory strategies, manage IND/NDAs submissions, ensure dossier quality and compliance, and coordinate cross-functional teams while interfacing with the FDA and other health authorities. This role emphasizes hematology/oncology focus and lifecycle activities.