If you’re interested in a career in regulatory affairs, you’ll want to read this post. We’ll discuss what a regulatory affairs career entails, and we’ll also offer some tips for breaking into the field.
A regulatory affairs career path is a great choice if you’re looking for a challenging and rewarding job. Regulatory affairs professionals are responsible for ensuring that products meet government regulations. This can involve anything from reviewing product proposals to ensuring that products are compliant with safety standards.
The work requires a mixture of analytical skills and the ability to find solutions to complex problems.
At its core, regulatory affairs are about risk management. Regulatory affairs professionals must ensure that products are safe for use by patients, consumers, or workers. In addition, they must also take into account environmental factors such as how long a product can be stored before it expires, how well it will function when used in various climates, and so on.
The work requires a mixture of analytical skills and the ability to find solutions to complex problems. Regulatory affairs professionals typically have backgrounds in science or engineering.
1. What are Regulatory Affairs?
In a nutshell, regulatory affairs is the coordination of all activities associated with the development, assessment, and management of drugs within the context of international drug regulations. In other words, it’s the practice of assuring that a product meets legal requirements in a given country or market in which it is to be sold. It also involves assuring compliance with local requirements and related trade requirements, such as labeling and marketing practices.
Regulatory affairs are an important element within the pharmaceutical industry that often goes unnoticed by most executives. Companies that excel at this function are very successful at not only bringing products to market faster than competitors but also running smoother operations with far fewer problems. The reason for this lies in the fact that was achieving such excellence targets timely and accurate submissions to market authorities (e.g., FDA, EMA), thus expediting time-to-market and avoiding costly clinical trial failures.
Regulatory affairs also ensure that products are safe for consumers. For the pharmaceutical industry, the main agency involved in assuring product safety and quality is the FDA (Food and Drug Administration). The FDA is responsible for protecting and promoting public health through the regulation of food and drug products marketed in the US. To fulfill these duties, they regulate manufacturers’ claims and labeling; monitor the advertising of drugs; review the results of clinical trials; inspect manufacturing facilities according to current Good Manufacturing Practice (cGMP) regulations; ensure that the content, quality, safety, and effectiveness of products is acceptable; track products after they enter the market; and work with other countries to facilitate the trade of safe and effective drugs.
2. How Can One Enter into Regulatory Affairs?
The regulatory affairs are the people who work to make sure that products on sale in different countries adhere to local laws. It is a profession with increasing demands for employees, which means there are many opportunities. The regulatory affairs can be done in two different ways:
1) A company hires an outside firm or consultant to take care of its regulatory obligations,
2) An individual works for an employer and handles the compliance side of things. For someone just entering this field, it may not seem clear what path to take. Both have their advantages and disadvantages so let’s break down each one.
Option 1 – Hiring a third-party firm or consultant: This option is generally less expensive but does mean you lose some control over your own regulatory affairs, and there is a risk that you could be overcharged.
Option 2 – Hiring an individual: This option generally means higher costs but gives greater control over the work being done. It may also mean that your company can build up valuable knowledge it can use for future compliance efforts. BOTH SIDES OF THE COIN: Both options require a lot of the same knowledge, skills, and abilities. There are some essential requirements to become a regulatory affairs consultant:
- 1) Knowledge of pharmaceutical/biotech regulation.
- 2) Good science background (biology, chemistry, or pharmaceuticals in).
- 3) Strong understanding of how to document and organize information in a clear and concise manner.
- 4) Ability to write reports in a form that is easy to understand.
- 5) Proven track record of being able to follow the rules and regulations set by governing bodies while creating plans for regulatory submissions, e.g., FDA Office of Compliance inspections for regulated products.
- 6) Understanding of the marketing lifecycle.
- 7) Excellent computer skills with experience in various software, e.g., Word, Excel, etc.
- 8) Ability to work under pressure and tight deadlines.
- 9) Clear communication skills are essential as you will be working on documents that may require frequent review/feedback from a number of different departments within your company.
- 10) Excellent time management skills are essential, as you will be managing your own schedule.
- 11) Ability to work independently with minimal supervision is also important in order to give off the appearance of self-sufficiency.
- 12) Flexible and willing to travel when needed, lots of trips out to FDA offices for conferences or inspections are common.
If you work for a company that does not have an in-house regulatory affairs department, it may be useful to know some additional skills that are useful when working as a consultant:
- 1) Familiarity with pharmaceuticals/biotech products and manufacturing processes is important, so if this knowledge already exists within your team, it can be useful when working with clients, especially when you have a client who is not familiar with the industry.
- 2) Business skills in order to understand your client’s business and needs in a way that enables you to provide a custom regulatory solution for them.
- 3) At least an intermediate level of knowledge of the English language in order to perform necessary tasks.
3. How do I Start a Career in Regulatory Affairs?
There are a number of different routes to take depending on your previous education, experience, and goals. For example, you could focus primarily on continuing your education with a Ph.D., but this will require at least five years postdoctoral research position that is closely related to the industry’s regulatory environment – definitely not an easy task.
You can also work your way up in a pharmaceutical company and get experience from the ground up. This option is good if you would like to make a switch eventually to another area of science, but it will take some time to build up that valuable knowledge about the industry’s regulatory environment.
It is important to note that although your background in science is essential when starting your career in regulatory affairs, it may not be enough to get you the position. It will definitely give you an advantage over individuals who do not have experience in science, but more importantly, it will provide critical decision-making skills that are necessary for understanding how the drug development process works.
In order to succeed as regulatory affairs professional, you will need to be confident in your scientific knowledge, but you must also have good people and communication skills.
4. What do Regulatory Affairs Earn?
Most people have no idea what regulatory affairs earn. They may have a vague notion that it’s a high-paying field, but they don’t know the specifics.
Regulatory affairs professionals are responsible for ensuring that products meet government regulations. This can be anything from food and drugs to cosmetics and environmental pollutants.
The job requires a lot of knowledge and expertise, as well as an understanding of how the government works. It’s no wonder then that regulatory affairs professionals earn a good salary.
>According to Salary.com, the average salary for a regulatory affairs manager is $107,867 per year. But this figure can vary widely depending on the level of experience and education you have.
In some cases, a Ph.D. is required for this position. In those cases, the salary jumps from $101,859 to as much as $116,042 per year.
> It’s also worth noting that regulatory affairs managers working for large organizations earn higher salaries than those employed by smaller companies.
5. What Skills are Needed for Regulatory Affairs?
Some of the skills needed for regulatory affairs include:
- – the ability to understand technology
- – strong interpersonal skills and a passion for working with people associated with regulatory affairs.
- – attention to detail and good organization skills
- – strong written and oral communication skills
- – some previous experience in a related field such as life sciences or engineering
6. What is the Job Outlook for Those Who Want to Pursue Regulatory Affairs?
According to Ira S. Wolfe of Regulatory Affairs Professionals Society, “the growth rate of new product development and the growth rate of new regulations means that the area of regulatory affairs will grow steadily. Regulatory Affairs Professionals Society forecasts that the industry for this profession will grow at a rate of 23 percent, or three times faster than the average.”
Secondary sources have also shown that although there are many people in the healthcare field who are needed to keep pace with an increasing number of regulations, anyone who is qualified and willing to study will be able to find a job.
7. What Types of Jobs are Available in the Regulatory Affairs Field?
If you look for a job that is less clinical, then you can get into the scientific side of things. If you want to go into a more clinical direction, then there are management-oriented positions in which one is “more of a public face representing the company, […] and interacting with the FDA and other regulatory agencies regarding product approval and compliance.”
You can also choose to go into consulting, where you can advise on how clinical trial regulations apply in different circumstances.
- – sales positions with pharmaceutical companies working as liaisons between regulatory affairs departments and sales offices
- – professional positions in the regulatory affairs field, such as medical writer
- – industry research positions funded by pharmaceutical companies to help market their products
- – industry research positions where one manages a team of people to conduct outreach activities
- – industry research positions where one conducts business analysis and data mining for pharmaceutical companies in order to help improve their marketing strategies.
8. What Types of Organizations Hire People for Jobs in Regulatory Affairs?
The pharmaceutical industries are the most known place where you can find people working in this field. But also other companies can employ regulatory affairs professionals,
In order to be hired, there are certain requirements that an applicant must have met before being able to be considered for a position in regulatory affairs. These requirements include:
- – at least two years of directly related experience in the pharmaceutical industry or one year if you have a relevant master’s degree
- – passing the CDER Medical Writer Certification Exam within one year
- – completing the medical writing training program, if it is required by your potential employer. Often times this training is paid for by your future employer.
- – familiarity with US FDA regulations
- – familiarity with international regulatory affairs (e.g., European Union) is a plus
9. What is the Difference Between a Regulatory Affairs Associate and a Regulatory Affairs Manager?
A regulatory affairs associate focuses on providing regulatory advice to ensure that regulations are followed. They have limited managerial responsibilities and do not typically supervise staff. A regulatory affairs manager coordinates the activities of others in their department and provides guidance and support to lower-level staff. They are responsible for managing staff, including hiring and firing. They also determine what the department’s goals are and create action plans to meet those goals.
10. How Long does it Usually Take to Get A Job in Regulatory Affairs?
It depends on the position you apply for, of course, but also how qualified you are. It can take between two months up to six months. It also depends on your experience and if you have a master’s degree. According to the International Regulatory Affairs Society (IRAS), it can take anywhere from “two months for junior positions up to six months for senior-level positions.”
11. Top Recruiting Companies for Regulatory Affairs Professional
If you’re looking for a job in regulatory affairs, you’ll be happy to know that there are many top recruiting companies that can help you find the perfect position.
Some of these companies include:
- – KPMG
- – PwC
- – IQVIA
- – ERT
- – Deloitte
- – Regulatory Specialists, Inc.
Each of these companies has a variety of jobs available and can help match you with the perfect company depending on your qualifications and experience.
12. Why Should I Work in Regulatory Affairs?
If you want to make a real difference in the world and help people, then regulatory affairs are the career for you. In regulatory affairs, you work with products that affect people’s health and safety. You make sure that these products are safe and effective and that the information about them is accurate and up-to-date. This is important work because it helps to keep people safe and healthy.
Regulatory affairs is also an interesting field because it is so dynamic. Unlike many other careers, regulatory affairs changes over time as new research findings come to light and more information about products becomes available. So you must be flexible in your job and always willing to learn new things.
13. Best Colleges to Study Regulatory Affairs
There are a number of colleges that offer regulatory affairs courses and programs. However, not all of them are created equal. Here is a list of the best colleges to study regulatory affairs:
1. Johns Hopkins University
2. University of Michigan
3. George Washington University
4. Northeastern University
5. Rutgers, The State University of New Jersey
The regulatory affairs career path can be both challenging and rewarding. It’s a great choice for those who want to make a difference in the world by helping protect public health and safety. If you have an interest in science and policy, this may be the perfect career for you. We hope this article has given you some insight into what it takes to pursue a career in regulatory affairs.