Regulatory Affairs Specialist
Peregrine Team · Raleigh, NC, US
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- Location
- Raleigh, NC, US
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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