Senior Research Associate

Job Summary

A company is looking for a Senior Research Associate.

Key Responsibilities

• Manage analytical release and stability testing of clinical development products
• Review and approve GMP testing data and manage relationships with external laboratories
• Author regulatory dossier sections and oversee Drug Substance and Drug Product stability studies

Required Qualifications

• Master's degree in Regulatory Affairs, Pharmacy, Biochemistry, Biology, or a related science field
• 3 years of related experience in regulatory sections authoring and content verification
• Experience in GMP testing data review and data integrity checks
• Familiarity with validated systems like EDMS and tools such as TrackWise and VEEVA
• Demonstrated interpersonal and organizational skills