Regulatory CMC Lead – Medical Devices & Combos

Organon LLC; Florham Park (NJ); Ibrido; USD 125.000 - 213.000; Tempo pieno

Descrizione del lavoro

Organon seeks an Associate Principal Scientist to lead regulatory CMC strategies for assigned small molecules. You will head the preparation and submission of CMC dossiers for lifecycle maintenance, original registrations, and post-approval changes, coordinating a small team or outsourcing partners as needed.

You will guide global regulatory strategy, assess risks, and ensure documentation meets regulatory expectations while collaborating with Manufacturing & Supply to support product continuity

Competenze

• Bachelor’s degree in science, engineering, or related field.
• Advanced degree (MS, MBA, Ph.D., PharmD) with relevant experience.
• Proficient English; additional languages a plus.

Mansioni

• Serve as the CMC Product Lead for assigned products and deliver regulatory milestones.
• Lead development and execution of global regulatory strategy(s) for CMC changes.
• Develop, author, and review CMC submission components for life-cycle and post-approval activities.
• Provide regulatory leadership for in-license/due diligence and product during divestment or withdrawal.
• Collaborate with Manufacturing & Supply and external partners on compliant change management.
• Manage CMC documentation including post-approval supplements and annual reports.

Conoscenze

CMC strategy

Regulatory submissions

Regulatory affairs

Leadership

Written communication

Formazione

Bachelor's degree in science/engineering

Advanced degree (MS/MBA/PhD/PharmD)

Descrizione del lavoro

Organon seeks an Associate Principal Scientist to lead regulatory CMC strategies for assigned small molecules. You will head the preparation and submission of CMC dossiers for lifecycle maintenance, original registrations, and post-approval changes, coordinating a small team or outsourcing partners as needed.

You will guide global regulatory strategy, assess risks, and ensure documentation meets regulatory expectations while collaborating with Manufacturing & Supply to support product continuity