Regulatory Affairs Specialist Job at Peregrine Team, Raleigh, NC

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  • Peregrine Team
  • Raleigh, NC

Job Description

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

Job Tags

Full time

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