Regulatory Affairs

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 labeling, including package inserts and container labels, Medication Guides, for the review, approval, tracking and archiving and submission.

Maintain controlled records of historical current and previous labeling changes, submit the relevant supplements.

Reviewing Chemistry, Manufacturing, and Controls (CMC) and Good Manufacturing Practices (GMPs) data for adequacy and conformance to regulatory requirements and acceptability of documents for submission.

Qualifications:

Bachelor s 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.

Proficiency in applicable computer and database applications (i.e. MS Word, Ms Excel, PDF, eCTD submissions software, labeling design software etc.) as well as applicable knowledge in FDA regulations and FDA/ICH guidelines.