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11-9199.01 — Regulatory Affairs Managers

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	Provide responses to regulatory agencies regarding product information or issues.
	Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
	Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
	Develop regulatory strategies and implementation plans for the preparation and submission of new products.
	Manage activities such as audits, regulatory agency inspections, or product recalls.
	Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
	Maintain current knowledge of relevant regulations, including proposed and final rules.
	Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
	Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
	Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
	Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
	Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
	Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
	Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
	Train staff in regulatory policies or procedures.
	Develop and maintain standard operating procedures or local working practices.
	Participate in the development or implementation of clinical trial protocols.
	Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
	Contribute to the development or implementation of business unit strategic and operating plans.
	Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
	Coordinate internal discoveries and depositions with legal department staff.
	Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
	Establish regulatory priorities or budgets and allocate resources and workloads.
	Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
	Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
	Monitor regulatory affairs trends related to environmental issues.
	Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.