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Regulatory Affairs Associate

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Levittown, PA

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Regulatory Affairs Associate: Require a min. of a Master's degree in drug regulatory affairs, pharmaceutics, pharmacy or related field. Plan and coordinate regulatory activities to ensure compliance with regulations and SOPs. Review, file and obtain approvals, amendments, supplements (SUPAC), site changes, annual reports and CMC sections of ANDA's, IND's & NDA's. Plan, schedule and conduct regulatory audits to ensure regulatory compliance. Establish systems for internal and external audits. Provide regulatory support to Marketing, Manufacturing, R & D, and QC departments on regulatory and compliance issues. Interact with FDA, DEA and other regulatory agencies on day-to-day activities such as follow-ups for status of various regulatory submissions and inspections. Coordinate preparation, review and approval of labels, inserts and cartons. Work under limited supervision. Knowledge of regulatory filings requirement for ANDAs, regulatory compliance, and regulatory audits. Proof of knowledge required. *** Research Scientist: Require a min of a Bachelor's degree or equivalent degree in pharmacy, chemistry or related field and 60 months of exp. Perform analytical procedures and testing using HPLC, GC, FTIR, UV-VIS spectrophotometer, Transdermal Diffusion Tester and Dissolution apparatus. Conduct analytical method development and validation for assay and impurity profile for drug substance and drug products. Write validation protocols, reports and test methods. Prepare SOPs for instruments and lab procedures. Perform qualification and calibration of analytical instruments. Work under limited supervision. Knowledge of HPLC, GC, FTIR, UV-VIS spectrophotometer, Transdermal Diffusion Tester and Dissolution apparatus required. Conversant with cGLP, cGMP, USFDA and ICH guidelines. Proof of knowledge required. *** Work location: Warminster, PA. Mail resume to Douglas Pharma US, Inc., 1035 Louis Drive, Warminster, PA 18974
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