Regulatory Affairs Specialist

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