What does a regulatory affairs specialist do?

1 What is regulatory affairs?

Regulatory affairs is the function that ensures that products and services comply with the relevant laws, regulations, standards, and guidelines in the countries or regions where they are intended to be sold or used. Regulatory affairs specialists are responsible for researching, preparing, submitting, and maintaining the documentation and communication with the regulatory authorities and other stakeholders throughout the product lifecycle. They also monitor and update the changes in the regulatory environment and advise the management and the development teams on the best strategies to achieve compliance and market access.

2 What are the main tasks of a regulatory affairs specialist?

A regulatory affairs specialist may be responsible for a variety of tasks depending on the industry, product type, company size, and level of experience. Common tasks can include conducting regulatory intelligence and analysis to identify requirements and opportunities, developing and implementing regulatory plans, submitting high-quality submissions to authorities, coordinating with external parties , maintaining databases and records, providing guidance and training to internal teams, and evaluating the impact of regulatory changes. Additionally, they may collaborate with other functions such as quality assurance, clinical research, manufacturing, marketing, and legal.

3 What are the skills and qualifications of a regulatory affairs specialist?

To become a successful regulatory affairs specialist, you need to possess a variety of technical, business, and soft skills, as well as relevant qualifications. For example, a bachelor's degree or higher in a scientific or related field such as biology, chemistry, pharmacy, engineering, or law is essential. Additionally, certifications or diplomas from organizations like the Regulatory Affairs Professionals Society (RAPS) or the Organization for Professionals in Regulatory Affairs (TOPRA) are beneficial. Furthermore, a strong knowledge of scientific principles, the regulatory framework, and industry standards and best practices is important. Moreover, possessing an analytical mind to interpret and apply complex and evolving regulations and guidelines is required. Additionally, having a high level of attention to detail when preparing regulatory documents is key. Additionally, good communication skills to interact with internal and external parties along with project management skills to coordinate multiple tasks are vital. Finally, it’s important to have flexibility and resilience to cope with the uncertainty and changes in the regulatory environment.

5 What are the challenges of being a regulatory affairs specialist?

Being a regulatory affairs specialist can be challenging due to the tight deadlines, heavy workload, and frequent changes, as well as the high expectations from the regulatory authorities and management. Keeping up with the latest developments and trends in the regulatory field and industry sector is essential for success in this role. There may also be potential for conflict and frustration when there are differences in opinions, perspectives, and interests between the regulatory affairs function and other functions or parties. Unfortunately, there may be limited recognition or appreciation of the value and impact of the regulatory affairs role.