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
