Regulatory Affairs Specialist

Also called: Regulatory Associate

Prepares the submissions that convince the FDA a drug or device is safe and effective enough to sell.

A day in the life

Assembles a 10,000-page application, checks every section against FDA rules, and drafts answers to the agency's questions on a tight deadline.

Pay over a career

Starting
$60k
Typical
$90k
High
$140k

Industry estimate.

Approximate: anchored on Bureau of Labor Statistics data for a broader job group.

Training

Bachelor's degree (4-year), about 4 years after high school. Bachelor's in a life science; master's in regulatory science and RAC certification help.

Ways in: 4-year college, Graduate school, Certification. Training cost: $15k – $60k.

Majors to look at: Biology, Regulatory Science, Chemistry.

Outlook

Growing faster than average (about 5% over 10 years). Estimate.

Will it last? Our AI estimate

Medium risk in 5 years, high in 10. AI now assembles and cross-checks big FDA submissions; fewer specialists, focused on strategy and agency questions.

Start now, in high school

Classes: AP Biology, AP Government, English composition.

Official data: O*NET occupation 13-1041.

More Biomanufacturing, Quality & Regulatory careers

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.