Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
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Job DescriptionTakeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs Strategy Lead in Cambridge, MA with the following requirements: Bachelor’s degree in Biology, Chemistry, Pharmacy or related field or foreign academic equivalent. 8 years of related experience. Prior experience must include: Lead the Global Regulatory Team (GRT) and applicable sub-working groups and serve as direct point of contact with the FDA, accountable for US FDA submissions, addressing agency queries leading to approvals, and lead agency meetings including meeting preparation (4 yrs); lead REMS activities and submissions especially on REMS KAB surveys and Assessment Report submitted to the US FDA (3 yrs); perform regulatory submissions in eCTD format, per ICH and FDA guidelines, and global regulatory requirements/submissions; lead local product labeling and Core data sheet process while providing strategic regulatory guidance as an SME (4 yrs). Up to 30% travel required.
Apply on-line at and search for Req # R0092069.
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LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeClear All
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