Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02697 About our client Our client is a reputable R&D company based in PA. They focus on assisting pharmaceutical companies across the globe in product development. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Regulatory Affairs Manager Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide regulatory guidance during the development of branded and generic products 2) Ensure that development and filing activities adhere to current US regulations and guidelines 3) Formulate regulatory strategies for timely submissions to FDA 4) Manage and execute timely filing of high quality electronic submissions to FDA 5) Ensure that submission plans and activities adhere to regulations and guidelines 6) Participate actively with ANDA/NDA project teams 7) Handle project management function during the submission phase 8) Initiate and coordinate interaction with internal and external (sponsors) members of functional groups within the project teams to ensure proper communication of regulatory requirements and strategies related to the assigned projects 9) Lead the coordination, preparation and submission of all sections of ANDAs (labeling and clinical – bioequivalence, CMC) amendments and supplements to the applications that comply with the company’s strategies and timelines 10) Oversee the electronic compilation of ANDAs in the e-CTD format for the highest quality and compliance with FDA guidance 11) Interact with the FDA project managers and reviewers (as necessary) to obtain guidance on regulatory issues 12) Review and approve documents for new ANDA, and marketed products 13) Provide timely updates on project assignments 14) Review and approve annual reports and e-processing activities prior to FDA submission 15) Monitor the regulatory environment for emerging trends, new guidance and new developments that impact generic business 16) Participate in the development of regulatory procedures that adhere to company strategy and timelines Requirements 1) BS 2) Minimum 3 years of regulatory affairs experience 3) Experience in ANDA filing preferred 4) Excellent writing and communication skills
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