Associate Director Global Regulatory Sciences - 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

Role: Associate Director, Global Regulatory Strategy in Hematology/Oncology

leading regulatory development and lifecycle management for oncology therapeutics.

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, and lead interactions with FDA and other health authorities.

Qualifications

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

Preferred

extensive US regulatory submission experience, team leadership skills, project management expertise, and ability to influence cross-functional teams.

High-Value

focus on oncology (hemato-oncology), lifecycle management, FDA interactions, global submission planning, and cross-functional collaboration.

Work Setup

likely hybrid or onsite, with some travel required.