Regulatory CMC Biologics Scientist - Hybrid/Global Leader

Scorpion Therapeutics; Rahway (NJ); Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

Hybrid work setup

Job summary

Scorpion Therapeutics is seeking a Senior Scientist (R3) in Regulatory CMC Biologics to lead global regulatory strategies across development and post-approval for biologics products.

You will develop and execute robust CMC regulatory plans, manage INDs, BLAs, and post-approval variations, and ensure compliance with global agency requirements, with a Hybrid work setup in the US and travel as needed.

Qualifications

• B.S. in science or engineering required.
• 5+ years in Regulatory CMC with biologics/vaccine experience preferred.
• Experience with global regulatory submissions and post-approval variations.

Responsibilities

• Develop and execute robust CMC regulatory plans.
• Manage INDs, BLAs, and post-approval variations.
• Ensure compliance with global agency requirements.
• Escalate issues as needed.

Skills

Regulatory CMC expertise

Global regulatory strategy

Documentation management

eCTD familiarity

Education

Bachelor's degree in science or engineering

Tools

eCTD submission tools

Job description

Scorpion Therapeutics is seeking a Senior Scientist (R3) in Regulatory CMC Biologics to lead global regulatory strategies across development and post-approval for biologics products.

You will develop and execute robust CMC regulatory plans, manage INDs, BLAs, and post-approval variations, and ensure compliance with global agency requirements, with a Hybrid work setup in the US and travel as needed.