Regulatory Affairs Specialist

Raleigh, NC

Full Time

Mid Level

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

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Regulatory Affairs Specialist

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