Regulatory CMC Lead, Life-Cycle Products (Remote)

Organon; Heist-op-den-Berg; Remote; EUR 110,000 - 140,000; Full time

Job summary

Organon is seeking an Associate Principal Scientist to shape Regulatory CMC strategies for small molecules or biologics, ensuring alignment with global regulations and Organon procedures. You will lead the preparation and submission of CMC dossiers for life-cycle maintenance, original registrations and post-approval changes, and may supervise 1–2 contributors or outsourcing partners.

You will drive regulatory strategy, assess global requirements, and collaborate with Manufacturing & Supply to

Qualifications

• Bachelor’s or advanced degree with relevant experience in regulatory chemistry and manufacturing (CMC).
• Proven ability to review data and present scientific rationale clearly.
• Strong written and oral communication in multicultural settings.

Responsibilities

• Serve as CMC Product Lead for assigned products and manage regulatory milestones.
• Lead development and execution of global regulatory strategies for CMC changes.
• Author and review CMC submission components for post-approval changes and life-cycle maintenance.
• Provide regulatory leadership in due diligence, divestiture, or withdrawal activities as needed.
• Collaborate with Manufacturing & Supply to ensure compliant change management.
• Oversee CMC documentation delivery per established processes and systems.
• Assess regulatory risks and communicate mitigation strategies.
• Deliver milestones across the product lifecycle.

Skills

CMC regulatory strategy

Leadership

Regulatory writing

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering

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

Job description

Organon is seeking an Associate Principal Scientist to shape Regulatory CMC strategies for small molecules or biologics, ensuring alignment with global regulations and Organon procedures. You will lead the preparation and submission of CMC dossiers for life-cycle maintenance, original registrations and post-approval changes, and may supervise 1–2 contributors or outsourcing partners.

You will drive regulatory strategy, assess global requirements, and collaborate with Manufacturing & Supply to