Oversees all 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. 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. Investigates and addresses any reported issues of non-compliance. Requir ...es a bachelor's degree. Typically reports to top management. Manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function.More Show Less
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Position. Regulatory Affairs DirectorSummary : Lead the development of regulatory strategies and submissions.Collaborate with various departments such as R&D, Technical Operations, Clinical Development, etc. to advance the company’s drug portfolio and ensure its commercial success.Responsibilities : – Provide guidance for development programs in order to meet regulatory standards in the US and globally.– Offer strategic regulatory direction throu...