Director of Regulatory Affairs

Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.

Develop regulatory strategies and implementation plans for the preparation and submission of new products.

Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.

Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.

Contribute to the development or implementation of business unit strategic and operating plans.

Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.

Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

Establish regulatory priorities or budgets and allocate resources and workloads.

Develop and maintain standard operating procedures or local working practices.

Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.

Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.

Participate in the development or implementation of clinical trial protocols.

Coordinate internal discoveries and depositions with legal department staff.

Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.

Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.

Direct the preparation and submission of regulatory agency applications, reports, or correspondence.

Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.

Provide responses to regulatory agencies regarding product information or issues.

Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.

Monitor regulatory affairs trends that are related to environmental issues.

Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.

Manage activities such as audits, regulatory agency inspections, or product recalls.

Maintain current knowledge of relevant regulations, including proposed and final rules.

Train staff in regulatory policies or procedures.