Senior Regulatory CMC Scientist – Hybrid, Global Impact

Organon; Florham Park (NJ); Ibrido; USD 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work arrangement

Descrizione del lavoro

Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for assigned products in the United States. The role involves preparing and reviewing information for regulatory CMC dossiers for development and post-approval activities, with a strong emphasis on global regulatory conformance.

The candidate will lead CMC submission components, assess risks, and liaise with Manufacturing & Supply and external partners to ensure compliant change management.

Competenze

• Bachelor’s degree with at least 4 years relevant experience.
• Advanced degree with at least 2 years relevant experience.
• Direct experience in Regulatory CMC preferred.
• Proficient in English; additional language skills a plus.
• Strong communication and leadership skills.

Mansioni

• Input to global regulatory strategies by assessing CMC changes and identifying global regulatory requirements.
• Lead development, authoring and review of CMC submission components.
• Coordinate with Manufacturing & Supply and partners for compliant change management.
• Assess regulatory risks and propose mitigation strategies.
• Deliver regulatory milestones across the product lifecycle.
• Identify and communicate regulatory issues to Organon Regulatory CMC management as needed.

Conoscenze

Regulatory CMC knowledge

English proficiency

Scientific writing

Stakeholder communication

Project leadership

Formazione

Bachelor’s degree in science/engineering

Advanced degree (MS/PhD/MBA/PharmD)

Descrizione del lavoro

Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for assigned products in the United States. The role involves preparing and reviewing information for regulatory CMC dossiers for development and post-approval activities, with a strong emphasis on global regulatory conformance.

The candidate will lead CMC submission components, assess risks, and liaise with Manufacturing & Supply and external partners to ensure compliant change management.