Regulatory Affairs Associate
- Regulatory Affairs Associate
- Coordinate with other departments (Document Control, Quality Control, Quality Assurance, and Manufacturing) to obtain all the CMC documents required for ANDA, Supplements, Annual Reports and Amendments.
- Utilize eCTD publishing and SPL software systems as well as the ESG Gateway system in accordance with regulatory submission requirements.
- Assist the Director of RA to maintain compliance with Federal and State Regulatory Licenses including FDA, DEA and Import/Export.
- per company objectives by working with other departments (QA, QC, R&D) in accordance with company deadlines.
- Draft content for finished product labeling and prepare product labels with the help of outside approved vendor to ensure compliance with FDA regulations.
- Coordinate and compile all the documents necessary for quality regulatory filings in accordance with company SOPs GMPs, GLPs and other FDA guidelines for generic and OTC drug products.
- These filings include ANDAs, supplements (Prior Approval/CBE/Annual Reportable), responses to FDA action letters and annual reports to US FDA in eCTD format.
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