Peregrine Team is seeking a Regulatory Affairs Specialist to support global regulatory submissions and ensure compliance across pharmaceutical products.
This role will work closely with cross-functional teams to support product approvals and lifecycle management.
Key Responsibilities Prepare and submit regulatory filings (IND, NDA, BLA, etc.) Track and interpret regulatory requirements across global markets Support product lifecycle management and labeling updates Collaborate with QA, clinical, and manufacturing teams Maintain regulatory documentation and databases Qualifications Bachelor’s degree in Life Sciences or related field 3–6+ years of regulatory experience in pharma/biotech Knowledge of FDA and international regulatory guidelines Strong writing and analytical skills Powered by JazzHR
Regulatory Affairs Specialist • Raleigh, NC, US