Regulatory affairs requires both technical skills and the ability to think strategically. Excellent oral and written communication skills are needed because the regulatory professional is frequently interacting with other departments in the company and externally. The ability to interpret data is also critical, whether it is data to support a particular product claim or the results of product analysis. Strategic thinking is also important. Thinking through the best strategy could have a major impact on launch timings or marketing claims, which could affect the overall success of the product.
Responsibilities vary depending on both product category and geography.
A 'local' regulatory manager may be responsible for one or two countries and several product categories and may be the only technical person in the local subsidiary company. There are just as many differences depending on the product category, but some activities are broadly the same. The difference between an unacceptable and an acceptable claim can hinge on small changes, so this is an opportunity to be creative. Other activities might include providing expert input to development programmes on the type and amount of data required, or preparing and submitting technical data to external authorities, then liaising with them to negotiate issues and achieve approval. Finally it may involve reviewing new legislation for its potential impact on the company and lobbying for any necessary changes.