Job Summary

A business services company has an open position for a Remote Senior Regulatory CMC Strategist .

Individual must be able to fulfill the following responsibilities:

• Developing and reviewing key technical documentation
• Ensuring successful outcomes with regulators
• Facilitating a smooth path to licensure

Position Requirements Include:

• Ability to travel ~25% of the time
• 6 to 10+ years' experience guiding biotechnology products through the development life cycle
• Experience with complex biologics and cell and gene therapies
• Experience with live and attenuated virus vaccines
• Experience with microbiome therapies and small molecules
• Experience with mammalian, bacterial, yeast, and insect host cell lines