Regulatory Affairs Associate

The incumbent selected for this position is expected to: Write, critically review, evaluate, compile and publish FDA submissions (ANDAs, amendments, supplements, annual reports and additional documentation, as needed) in eCTD format. Development of product labelling, including package inserts and container labels, Medication Guides, for the review, approval, tracking and archiving and submission. Qualifications: Bachelors degree in Pharmacy or Chemistry combined with about 2 or more years of hands-on experience of ANDAs filings and other regulatory submissions with USFDA is required.