Associate Principal Scientist, CMC Strategy Lead

Organon LLC; Jersey City (NJ); Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Organon LLC is seeking an Associate Principal Scientist to lead regulatory CMC strategies for assigned products. You will drive global CMC submissions and life-cycle activities, coordinating cross-functionally with manufacturing, quality, and external partners to maintain regulatory conformance.

You will oversee documentation, assess regulatory risks, and contribute to due diligence, licensing, and product lifecycle milestones as part of a dynamic regulatory team.

Qualifikationen

• Bachelor’s degree in a science, engineering, or related field.
• Fields of study include Pharmacy, Chemistry, Chemical Engineering, etc.
• Experience developing and governing regulatory CMC strategies is preferred.

Aufgaben

• Lead development and execution of global CMC regulatory strategy for assigned products.
• Oversee preparation and submission of CMC dossiers for life-cycle and post-approval changes.
• Collaborate with manufacturing and external partners to ensure regulatory conformance.
• Provide regulatory leadership for due diligence, in-licensing, divestment or withdrawal efforts.

Kenntnisse

CMC regulatory knowledge

Regulatory strategy leadership

Cross-functional collaboration

Documentation writing

Team leadership

Ausbildung

Bachelor’s degree in science or engineering

Jobbeschreibung

Organon LLC is seeking an Associate Principal Scientist to lead regulatory CMC strategies for assigned products. You will drive global CMC submissions and life-cycle activities, coordinating cross-functionally with manufacturing, quality, and external partners to maintain regulatory conformance.

You will oversee documentation, assess regulatory risks, and contribute to due diligence, licensing, and product lifecycle milestones as part of a dynamic regulatory team.