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Director, Regulatory Affairs #20201034
SHILPA PHARMA, INC. | |
United States, Pennsylvania, Doylestown | |
March 29, 2023 | |
Director, Regulatory Affairs -Doylestown, PA: Represent pharma company in communicating with US FDA for regulatory submissions: ANDAs, NDAs, DMFs, amendments, supplements & annual reports. Provide CMC strategies & coordinate preparation of submissions to FDA for companies new [ANDAs (505j) & NDAs (505b2 & 505b1)] & marketed products. Required: Master's degree (or U.S. equvalent) in Regulatory Affairs or Pharmaceutical Sciences. 7 years experience in regultry affairs in genric pharma company. Experience in strategy, preparation, review & submission of ANDA/NDA/CMC/Supplements/Amendments/ANDS & regulatory submissions & handling various dosage forms like parenterals, solid oral tablets, & capsules per FDA guidelines to obtain approval of generic & new drug products fr US market. Experience in analyzing, preparing, assembling, compiling, publishing regulatory submissions in electronic format (eCTD), reviewing documentation including SOPs & training of regulatory teams required. Experience in reviewing labeling advertising & promotional labeling, ensure regulatory compliance to policies & guidelines required. Perform of legal authority to work in US required. recblid 9hmk7k2g1yc1j0ibysryk4k7cus9ft |