Regulatory affairs specialists assist in getting new products approved by regulatory agencies. They also maintain records on existing products.

Regulatory affairs specialists work with regulatory affairs managers to help companies comply with regulations. They must submit regular reports for existing products. They also help companies follow rules for new products. Products need testing to ensure that they meet health, environmental, and safety standards.

Regulations often change, so specialists must stay up to date. New rules address issues such as:

• Recycling
• Toxic waste
• Climate change
• Genetically altered crops

Specialists must help others understand regulatory issues and what changes have to be made. They often communicate changes in memos, reports, manuals, and guides. When a product is changed, these specialists report to agencies and make sure their companies comply with all the rules and regulations.

Sometimes making a product creates pollution. In these cases, specialists need to know all the rules dealing with the storage, transport, or disposal of the pollution. If the product is sold outside the United States, they need to know the rules for other countries too.

Regulatory affairs specialists must be highly organized, detail-oriented, and good writers. They must be able to respond to requests for more information from agencies. Keeping complete, updated records is a key part of this job.