Associate Principal Scientist – Regulatory Chemistry, Manufacturing and Controls (CMC) Product Lead

Role Overview

• Serve as the CMC Product Lead for assigned products
• Lead development and execution of global product and project regulatory strategies
• Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation
• Provide regulatory leadership as needed to product in-license/due diligence review
• Collaborate with Organon Manufacturing & Supply colleagues and external partners
• Manage execution of CMC documentation including post-approval supplements and annual reports
• Assess and communicate potential regulatory risks and propose mitigation strategies
• Identify, communicate and escalate potential regulatory issues to management as needed

Requirements

• Bachelor’s degree in a science, engineering, or a related field
• At least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience
• Proficient in English; additional language skills are a plus
• Proven experience in critically reviewing detailed scientific information
• Demonstrated superior oral and written communication skills
• Strong listening skills
• Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance)

Benefits

• Retirement savings plan
• Paid vacation and holiday time
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage