Also called: Chemistry, Manufacturing & Controls Regulatory Lead
Writes the parts of FDA applications that prove a drug can be made consistently and safely.
Gathers manufacturing and testing data, writes the CMC section of a new drug application, and handles FDA questions about a process change.
Estimate.
Approximate: anchored on Bureau of Labor Statistics data for a broader job group.
Master's degree, about 8 years after high school. Bachelor's or master's in chemistry or biology plus years of manufacturing or QC experience.
Ways in: 4-year college, Graduate school. Training cost: $15k – $60k.
Majors to look at: Chemistry, Biochemistry.
Growing about average. Steady.
Medium risk for 10 years. AI drafts CMC sections from data; judgment on process changes and answering the FDA stay human.
Classes: AP Chemistry, AP Biology, English composition.
Official data: O*NET occupation 11-9199.
Career Universe is an early version. Pay, training and AI-risk figures are estimates to start your own research, not verified facts. The research was written with AI research assistants, checked by validation scripts and spot-checked by hand. Check anything important with schools, employers and official sources. How the numbers work.