Unknown Company

Regulatory Affairs Specialist

raleigh, nc • Posted 1 weeks ago
Onsite Full Time General

Regulatory Affairs SpecialistPeregrine 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 ResponsibilitiesPrepare and submit regulatory filings (IND, NDA, BLA, etc.)Track and interpret regulatory requirements across global marketsSupport product lifecycle management and labeling updatesCollaborate with QA, clinical, and manufacturing teamsMaintain regulatory documentation and databasesQualificationsBachelor's degree in Life Sciences or related field3–6+ years of regulatory experience in pharma/biotechKnowledge of FDA and international regulatory guidelinesStrong writing and analytical skills

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