Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control

Merck; Rahway (NJ); Sur place; USD 120 000 - 190 000; Plein temps

Avantages offerts par ce poste

Hybrid work setup

Résumé du poste

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.

Responsabilités

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

Connaissances

Regulatory CMC expertise

Global regulatory strategy

Documentation management

eCTD familiarity

Formation

Bachelor's degree in science or engineering

Outils

eCTD submission tools

Description du poste

Role: Senior Scientist (R3) in Regulatory CMC Biologics, leading global regulatory strategies and project management for biological products throughout development and post-approval.

Responsibilities: develop and execute robust CMC regulatory plans, manage documentation such as INDs, BLAs, and post-approval variations, ensure compliance with global agency requirements, and escalat[>???] issues as needed.

Requirements: B.S. in a science or engineering field; 5+ years in Regulatory CMC, with biological or vaccine product experience preferred.

High-Value: biologics, vaccines, Regulatory CMC, global product lifecycle management, regulatory documentation, compliance, experience with eCTD; hybrid work setup; US-based with potential travel.