Senior Regulatory CMC Scientist — Hybrid Role

Organon LLC; Florham Park (NJ); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Retirement savings plan

Paid vacation and holidays

Parental leave and medical leave

Comprehensive health benefits

Job summary

Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for small molecules or biologics, ensuring alignment with global regulations and strategies.

You will prepare and review information for regulatory CMC dossiers, lead development, authoring and review of submission components, and drive milestones across the product lifecycle in a collaborative, cross-functional environment.

Qualifications

• Bachelor’s degree in science/engineering or related field with relevant experience.
• Advanced degree plus experience in regulatory CMC preferred.
• Proficient English; additional languages a plus.

Responsibilities

• Provide input to global regulatory strategies and assess regulatory requirements.
• Lead development, authoring and review of CMC submission components.
• Coordinate with manufacturing and external partners for change management.
• Assess risks and communicate mitigation strategies; deliver milestones.

Skills

Regulatory CMC experience

English proficiency

Leadership

Project management

Strong communication

Education

Bachelor’s Degree in science/engineering/related field

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

Job description

Organon is seeking a Senior Scientist to implement Regulatory CMC strategies for small molecules or biologics, ensuring alignment with global regulations and strategies.

You will prepare and review information for regulatory CMC dossiers, lead development, authoring and review of submission components, and drive milestones across the product lifecycle in a collaborative, cross-functional environment.