Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. They are often employed by pharmaceutical, biotechnology, and medical device companies. They may also work in government or law. The duties and responsibilities of Regulatory Affairs Specialists have expanded in recent years as a result of company acquisitions and restructuring, worldwide globalization of markets, and constantly evolving regulations. Typically, individuals in these positions work within an office of regulatory affairs where they work on document preparation, information management, file maintenance, and coordination of tasks across multiple departments. Part of their strategic directive is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. They help review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. In addition, they determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
A variety of job titles may be used in this profession, including Clinical Quality Assurance Associate or Specialist, Drug Regulatory Affairs Specialist, Product Safety Specialist, Quality Assurance Documentation Coordinator or Specialist, Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist), Regulatory Affairs Analyst, and Regulatory Affairs Associate. Some typical job tasks include:
- Explain regulations, policies, or procedures
- Maintain data in information systems or databases
- Ensure compliance with regulations
- Advise others on regulatory and compliance matters
- Evaluate applicable laws and regulations to determine impact on company activities
- Provide technical review of data or reports
- Coordinate regulatory documentation activities
- Identify and interpret relevant regulatory guidelines
Regulatory affairs positions have increasing levels of responsibility and more senior individuals typically assume titles of manager or director. Jobs in this field are likely to increase due to expanding government regulation within the health and pharma industries.
Regulatory Affairs Specialists must be able to work in a demanding environment where strict timelines and protocols must be met. They frequently work on managing and documenting information, and must be adept at working with databases and other information management tools. Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions are full time. Some may work in contractor or consultant roles associated with a specific product. Others may be longer-term roles covering a wider array of products. Since they need to keep up to date on their area of expertise, attendance at professional conferences or relevant training events is common.
Entry-level regulatory affairs professionals have a bachelor’s degree. Typical majors include biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and engineering. Coursework in law, marketing, business, and statistics is also useful. Those who advance in the profession often have a masters (e.g., in business administration, clinical research studies, engineering, or a life science) or a terminal degree (e.g., PhD, MD, or PharmD). Advancement may require credentialing, for example via a Regulatory Affairs Certification (RAC).