Regulatory Affairs Associate II
Core
Prepare, review, and submit high-quality regulatory submissions to the FDA, including Annual Reports, supplements, and post-approval changes.
Role type
Mid-level Regulatory Affairs Associate
Builds
FDA regulatory submissions (ANDAs, Annual Reports, supplements)
Domain
Biopharmaceuticals / Generics / FDA Compliance
Required skills
Regulatory submission preparation, FDA guideline compliance, Change control evaluation, Database management, Documentation compilation
Preferred skills
M. Pharma degree, 4+ years pharmaceutical industry experience, QA or laboratory experience
Technologies
Microsoft Word, Microsoft Excel
Responsibilities
Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports; Proactively request and compile documentation for annual reports; Work independently on simple supplements and assist on complex ones; Evaluate change controls for post-approval changes; Train Associate I's on internal processes and databases.
