CMC Regulatory Lead, Associate Principal Scientist

Organon LLC; Florham Park (NJ); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Organon LLC is seeking an Associate Principal Scientist to develop and implement Regulatory CMC strategies for small molecule or biologics, leading CMC dossiers for lifecycle changes and registrations. This role may manage 1–2 contributors or outsourcing partners and supports project goals across regulatory teams.

The candidate will lead cross-functional activities, ensure regulatory conformance, and drive timely product supply while collaborating with Manufacturing & Supply and external

Competenze

• Experience leading CMC regulatory submissions and life-cycle maintenance.
• Ability to assess global regulatory requirements and risks.
• Strong written and oral communication in English, with ability to distill complex data.

Mansioni

• Serve as CMC Product Lead for assigned products and deliver regulatory milestones.
• Lead development and execution of global regulatory strategy for CMC changes.
• Create, review and author CMC submission components for post-approval changes.
• Provide regulatory leadership for in-licensing, due diligence, divestiture and withdrawals.
• Collaborate with manufacturing and external partners to ensure regulatory conformance.
• Manage CMC documentation for post-approval supplements and annual reports.
• Identify regulatory risks and propose mitigation strategies.

Conoscenze

Regulatory strategy

CMC submissions

Team leadership

English proficiency

Regulatory risk assessment

Formazione

Bachelor’s degree in science/engineering

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

Descrizione del lavoro

Organon LLC is seeking an Associate Principal Scientist to develop and implement Regulatory CMC strategies for small molecule or biologics, leading CMC dossiers for lifecycle changes and registrations. This role may manage 1–2 contributors or outsourcing partners and supports project goals across regulatory teams.

The candidate will lead cross-functional activities, ensure regulatory conformance, and drive timely product supply while collaborating with Manufacturing & Supply and external