Katalyst CRO
Overview
Join to apply for the
Regulatory Affairs Associate
role at
Katalyst CRO . Responsibilities
Prepare, review and submit high-quality FDA annual reports within required timelines and in accordance with regulatory guidelines and applicable federal laws. Compile and complete annual reports of high quality, following regulatory guidelines and internal processes within established timelines. Coordinate with supporting departments to obtain documents for annual report submissions. Archive and maintain all post-approval submissions in the RA library in a systematic way. Assist in projects assigned to the Post-Approval team (Client, CBE-30, CBE0). Assist the technical services team by providing required information from the submissions as needed. Organize and maintain submission components electronically for regulatory submissions (this may include scanning, converting to PDF, bookmarking, hyper-linking, electronic processing and uploading in e-CTD Xpress, under guidance). Gain knowledge in the use of e-CTD structures for submissions. Work with colleagues to resolve regulatory issues and/or problems. Perform administrative functions as directed by Management to support projects and ensure smooth department operations. Maintain current knowledge of regulations and other issues that affect products and the industry. Maintain regulatory databases up to date in accordance with defined criteria. Requirements
Masters degree in Science or a technical field, with at least 3 years of experience in the pharmaceutical industry. Regulatory affairs or related coursework. Working knowledge and experience with 21 CFR, US FDA guidance, and ICH guidelines. Strong computer skills and the ability to learn new programs quickly. Experience with MS Word, Excel, Outlook and Adobe Acrobat is a must. Time management, organization and planning skills; ability to multitask and prioritize in a fast-paced environment. High level of accuracy and attention to detail while meeting deadlines. Excellent written and verbal communication skills and interpersonal skills. Ability to communicate effectively and collaboratively as part of a team in a respectful manner. Ability to work independently and be a self-starter. Strong problem-solving and analytical abilities. Seniority level
Associate Employment type
Contract Job function
Legal Industries
Pharmaceutical Manufacturing
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Join to apply for the
Regulatory Affairs Associate
role at
Katalyst CRO . Responsibilities
Prepare, review and submit high-quality FDA annual reports within required timelines and in accordance with regulatory guidelines and applicable federal laws. Compile and complete annual reports of high quality, following regulatory guidelines and internal processes within established timelines. Coordinate with supporting departments to obtain documents for annual report submissions. Archive and maintain all post-approval submissions in the RA library in a systematic way. Assist in projects assigned to the Post-Approval team (Client, CBE-30, CBE0). Assist the technical services team by providing required information from the submissions as needed. Organize and maintain submission components electronically for regulatory submissions (this may include scanning, converting to PDF, bookmarking, hyper-linking, electronic processing and uploading in e-CTD Xpress, under guidance). Gain knowledge in the use of e-CTD structures for submissions. Work with colleagues to resolve regulatory issues and/or problems. Perform administrative functions as directed by Management to support projects and ensure smooth department operations. Maintain current knowledge of regulations and other issues that affect products and the industry. Maintain regulatory databases up to date in accordance with defined criteria. Requirements
Masters degree in Science or a technical field, with at least 3 years of experience in the pharmaceutical industry. Regulatory affairs or related coursework. Working knowledge and experience with 21 CFR, US FDA guidance, and ICH guidelines. Strong computer skills and the ability to learn new programs quickly. Experience with MS Word, Excel, Outlook and Adobe Acrobat is a must. Time management, organization and planning skills; ability to multitask and prioritize in a fast-paced environment. High level of accuracy and attention to detail while meeting deadlines. Excellent written and verbal communication skills and interpersonal skills. Ability to communicate effectively and collaboratively as part of a team in a respectful manner. Ability to work independently and be a self-starter. Strong problem-solving and analytical abilities. Seniority level
Associate Employment type
Contract Job function
Legal Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr