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Job #03631

About our client Our client is a biopharmaceutical company based in Wisconsin. They are a leading global supplier of high quality active pharmaceutical ingredients for nearly three decades. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Associate Regulatory Affairs Specialist Wisconsin Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist in preparing new and help maintain, existing Drug Master Files (DMFs) for US FDA and certificates of suitability for the European Community (EC) in Electronic Common Technical Document (ECTD) format 2) Keep current with the changing EC Drug Substance or Active Pharmaceutical Ingredient (API) registration requirements 3) Prepare document packages for clients in support of DMF, IND and NDA filings 4) Keep current with the changing FDA cGMP requirements, Code of Federal Regulations application to the DMFs, INDs and NDAs and USDA importation and exportation requirements 5) Collect, review interpret and summarize annual QC data deviations/discrepancies change control records, procedure history files and other appropriate documentation pertinent to the generation of Annual Update as per company procedures 6) Review USP/NF Pharmacopeial Forum Supplements and alert QC/QA to proposed and upcoming changes in the compendia (e.g. BP, EP and AOAC) and ensure compliance with such revisions in a manner similar to USP/NF updates 7) Help to prepare and maintain submissions to regulatory agencies and required compliance reports, such as Drug Master Files and Annual Updates an amendments to the DMFs in compliance with ICH Q7A and 21 CFR 314 8) Ensure appropriate follow up activities are carried out in a timely fashion to ensure analytical methods, labeling, product descriptions/specifications, raw material chemical descriptions specifications are updated within the required time frame 9) Serve as alternate for the Regulatory Affairs Manager to the change control committee 10) Participate in facility cGMP audits (customer driven and regulatory agencies) 11) Perform other duties projects as assigned Requirements 1) Bachelor’s degree in Life Sciences field such as Chemistry, Biology and Microbiology 2) Minimum of 2 years of previous experience in a cGMP pharmaceutical and laboratory, manufacturing site 3) Regulatory affairs experience including ECTD expertise (preferred) 4) Basic understanding of chemistry laboratory tests operation and/or activities 5) Working knowledge of MS Office suite 6) General knowledge of the purpose and function of SOPs, DMFS, INDs, NDAs and ANDAs 7) Detail-oriented individual with demonstrated ability to handle confidential material 8) Demonstrated proficiency in math 9) Excellent communication (written and oral) skills 10) Excellent interpersonal skills 11) Accurate typing skills (40 WPM) and proof-reading skills 12) Ability to judge and take initiatives and 13) Ability to regularly report for work 14) Ability to work longer hours and some weekends (as needed)