Regulatory CMC Scientist - Global Submissions & Strategy

Organon Comercializadora S de RL de C.V; Florham Park (NJ); In loco; USD 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for small molecules or biologics, ensuring compliance with global regulations. The role involves drafting and reviewing CMC dossiers and coordinating with Manufacturing & Supply and partners to support post-approval activities.

The candidate will lead regulatory assessments, identify risks, and deliver milestones across the product lifecycle, with strong English communication and leadership skills.

Competenze

• Bachelor’s Degree in science/engineering with at least 4 years in biological/pharmaceutical R&D or manufacturing.
• Advanced degree (MS, MBA, Ph.D., PharmD) with at least 2 years of relevant experience.
• Direct experience in Regulatory CMC preferred
• Proficient in English; strong communication skills

Mansioni

• Contribute to regulatory CMC strategies for products across the lifecycle.
• Author and review CMC submission components and regulatory documentation.
• Coordinate with Organon Manufacturing & Supply and external partners on change management.
• Assess regulatory risks and propose mitigation strategies.
• Deliver regulatory milestones for assigned products.
• Communicate potential regulatory issues to management when needed.

Conoscenze

Regulatory CMC expertise

English proficiency

Technical writing

Cross-functional collaboration

Project management

Formazione

Bachelor's degree in science/engineering

Advanced degree (MS, MBA, PhD, PharmD)

Descrizione del lavoro

Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for small molecules or biologics, ensuring compliance with global regulations. The role involves drafting and reviewing CMC dossiers and coordinating with Manufacturing & Supply and partners to support post-approval activities.

The candidate will lead regulatory assessments, identify risks, and deliver milestones across the product lifecycle, with strong English communication and leadership skills.