Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (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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