Remote Senior Regulatory Affairs Chemistry Manufacturing and Controls Manager

Job Summary

A biopharmaceutical company has an open position for a Remote Senior Regulatory Affairs Chemistry Manufacturing and Controls Manager.

Individual must be able to fulfill the following responsibilities:

• Proactively manage Chemistry, Manufacturing & Controls
• Author and review CMC modules of applications
• Author and review responses to health authority requests for information

Applicants must meet the following qualifications:

• Bachelor’s degree in life sciences in chemistry, molecular biology, immunology, or similar major
• 6 years’ experience in a biologics CMC function in the biotechnology industry
• Experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Demonstrated ability to work within a cross-functional matrix team environment