Regulatory CMC Lead Scientist — Remote

Organon; Philadelphia (Philadelphia County); Remoto; USD 150.000 - 200.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flex Time

Remote Work

Descrizione del lavoro

Organon is seeking an Associate Principal Scientist to lead Regulatory CMC strategies for assigned products in the US. The role involves steering dossiers for lifecycle changes, registrations, and post-approvals, plus guiding a small team or partners to meet regulatory milestones.

The candidate will influence product supply continuity, assess regulatory risks, and work with global stakeholders to ensure compliant change management and robust documentation.

Competenze

• Bachelor’s degree in a science, engineering, or related field with at least 7 years of relevant experience OR
• Advanced degree with at least 4 years of relevant experience.
• Proficient in English; additional language skills are a plus.

Mansioni

• Serve as the CMC Product Lead for assigned products and deliver regulatory milestones.
• Lead development and execution of global regulatory strategies and assess global requirements.
• Develop, author, and review CMC submission components for post-approval changes and registrations.
• Provide regulatory leadership for in-license/due diligence and product lifecycle management.
• Collaborate with Manufacturing & Supply to ensure compliant change management and regulatory conformance.
• Manage CMC documentation including post-approval supplements and annual reports.

Conoscenze

Regulatory strategy

Leadership

Communication

Team management

Formazione

Bachelor’s degree in science/engineering

Advanced degree (MS/MBA/Ph.D./PharmD)

Descrizione del lavoro

Organon is seeking an Associate Principal Scientist to lead Regulatory CMC strategies for assigned products in the US. The role involves steering dossiers for lifecycle changes, registrations, and post-approvals, plus guiding a small team or partners to meet regulatory milestones.

The candidate will influence product supply continuity, assess regulatory risks, and work with global stakeholders to ensure compliant change management and robust documentation.