Job Summary

A biopharmaceutical medical research firm is searching for a person to fill their position for a Remote Regulatory Affairs CMC Manager.

Core Responsibilities of this position include:

• Developing regulatory strategy for CMC content and lifecycle maintenance
• Identifying CMC risk areas and develop alternative courses of actions
• Aligning CMC regulatory strategy to overall regulatory business strategy

Qualifications Include:

• High School Degree and 11+ years of regulatory experience or equivalent
• 5+ years of experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry
• Organizational skills
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Ability to adapt in a constantly evolving environment
• Self-motivated with a strong sense of ownership in areas of responsibility