Salary, Job Description, How To Become One, and Quiz
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Regulatory Affairs Managers
Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Table of contents
What they do
Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
- Provide responses to regulatory agencies regarding product information or issues.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Typical day
On a daily basis, Regulatory Affairs Managers monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. They maintain current knowledge of relevant regulations, including proposed and final rules.
A typical day for a Regulatory Affairs Manager will also include:
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Provide regulatory guidance to departments or development project teams regarding the design, development, evaluation, or marketing of products.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Other responsibilities
Besides their typical day, Regulatory Affairs Managers also provide responses to regulatory agencies regarding product information or issues. They may also develop and maintain standard operating procedures or local working practices.
On a weekly to monthly basis, Regulatory Affairs Managers maintain current knowledge of relevant regulations, including proposed and final rules. They might also develop regulatory strategies and implementation plans for the preparation and submission of new products.
In addition, they provide regulatory guidance to departments or development project teams regarding the design, development, evaluation, or marketing of products.
Although specific duties may vary, many of them direct documentation efforts to ensure compliance with domestic and international regulations and standards.
To some Regulatory Affairs Managers, it is also their responsibility to review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
What is the job like
Job satisfaction
Is this job meaningful
75% said they were satisfied with their job and 62% said they found their job meaningful.
A day in the life of a regulatory affairs manager really depends on which side of the research you are on. My expertise is in academic research not industry. At the site level, the regulatory manager is responsible for ensuring day-to-day operations of clinical trials within the regulatory team are running smoothly. This means submitting applications (new studies, amendments, renewals, study closures, serious adverse events, etc.) to the Institutional Review Board; making sure all site regulatory documents are up to date and accurate; resolving regulatory issues (subject eligibility, protocol deviations, patient registrations, drug shipment delays, contracts, activations, etc.) The take home from this question is NO ONE DAY IS THE SAME.
Pros
The pros of regulatory affairs is that we’re always right! Just kidding, but not really. The regulations are in black and white for a reason. They cannot be changed. So, if one understands the regulations, there really is no need to go back and forth, say with a Principal Investigator, over an issue where regulatory has jurisdiction.
Additional pros are that as a regulatory manager, your job is multi-faceted and you work with various departments, which expands your skillset. For instance, one would need to ensure pharmacy, nursing (research & clinical i.e. infusion nursing), contracts, finance, investigators, etc. are on board to activate a study or are aware of changes with the release of an amendment that may affect their work. For instance, a sponsor could adjust the treatment or replace a drug being used. As a regulatory manager, it is your responsibility to inform pharmacy, confirm if the contract/budget needs to be revised, ensure investigators/nursing/coordinators understand the changes, etc. It is a great position to be in to learn all aspects of clinical research.
Cons
The flip side of that is that the responsibility can be stressful. Miscommunication is a major cause of deviations, or missing required steps that need to be taken (“Regulatory didn’t let us know, so we did not do xyz…”). The blame game often falls on Regulatory, but if up to the challenge, the reward is gratifying.
Another con of the job is that it can be very demanding. Regulatory could be the reason a patient does not go on trial, or that a deviation occurred (i.e. there is an error or worse OMISSION of important information in the consent form), or that an amendment was not submitted in time which leads to treatment delays. These are not examples: these are real world situations that have personally happened to me in my career.
Advice to students interested in getting into Regulatory
The great thing about regulatory is that various majors provide the skills you need. Of course, Science is a primary one (secret: the only science I took in college was Astronomy! But looking back I definitely would have taken more biology/chemistry courses). Many Regulatory Managers have degrees in Biological Sciences, English, Business, Law, Finance, even Psychology. I can offer up a little* advice about degrees in “Clinical Research.” I would only move towards this degree if you want to enter into pharma. They prepare you more for that career more so than academic clinical research. I’ve interviewed countless candidates with this degree and they all were trying to break into academia but were currently at or recently left a pharma job. I can also say even being at a director level, if I jumped to pharma, I would have to start at a lower level because again, pharma and site level clinical research run quite differently. Even when submitting to the FDA (i.e. IND application). I have done countless applications for investigators, but submitting for a manufacturer (pharma) is much more detailed and regimented.
I also have started my own brand Opinionated STEM. I want to show that STEM is fun and nothing to be intimidated by, and most importantly that there are so many areas of STEM (i.e. regulatory!) that does not require a medical degree or clinical license. I have a unique corner of the market because I’m not your typical clinical research professional. I have an opinion on everything! (all social media handles are @OpinionatedSTEM- shameless plug for you to check out!)
Pros
Suitable for people who like to start and carry out projects.
Suitable for people who value achievements and are results-oriented.
This career is perfect for people who love to work indoors.
One of the highest-paid careers in the world.
Cons
Not suitable for people who like to work with designs.
It is hard to get into this career. A considerable amount of work-related skill, knowledge, or experience is required for this career.
Long working hours (More than 40 hours per week).
How much do they make
Average salary
Average hourly wage
Entry-level Regulatory Affairs Managers with little to no experience can expect to make anywhere between $40,160 to $52,670 per year or $19 to $25 per hour.
| Salary by experience | Annual | Hourly |
|---|---|---|
| Highest (Top 10%) | $115,220 | $55 |
| Senior (Top 25%) | $95,330 | $46 |
| Median | $71,100 | $34 |
| Junior (Bottom 25%) | $52,670 | $25 |
| No experience (Bottom 10%) | $40,160 | $19 |
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What is the work day like
Working hours
Working schedule
How often do you use email in this job?
Telephone
How often do you have telephone conversations in this job?
Group discussions
How often do you have group discussions in this job?
Public speaking
How often does this job require you to do public speaking?
Level of competition
How much competitive pressure is in this job?
What is the work environment like
Office-style environment
Indoors in an environmentally controlled condition
Warehouse-style environment
Indoors in a non-controlled environmental condition such as a warehouse
Outdoors
Outdoors exposed to all weather conditions
Outdoors – Under Cover
Outdoors but under cover (e.g. structure with roof but no walls)
How to become one
Difficulty to become one
Required level of education
What level of education do you need to perform the job?
Relevant majors
Relevant work experience
How much related work experience do you need to get hired for the job?
On The Job Training
How much on the job training do you need to perform the job?
Should you become one
Best personality type for this career
People with this personality likes to start and work on projects. They also like leading people and making many decisions.
People with The Builder personality type likes practical and hands-on work. They prefer working with plants, animals, and real-world materials like wood, tools, and machinery.
People with The Thinker personality likes to work with ideas that require an extensive amount of thinking. They prefer work that requires them to solve problems mentally.
People with The Artist personality likes to work with designs and patterns. They prefer activities that require self-expression and prefer work that can be done without following a clear set of rules.
People with The Helper personality type likes to work with people and in teams. They prefer work that allows them to build relationships with others.
People with The Leader personality likes to start and work on projects. They also like leading people and making many decisions.
People with The Organizer personality type likes to follow set procedures and routines. They prefer working with data and details more than with ideas.
You can read more about these career personality types here.
People who are suitable for this job tend to like starting up and carrying out projects. They like leading people and making many decisions. Sometimes they require risk-taking and often deal with business.
They also like following set procedures and routines. They like working with data and details more than with ideas.
Take this quiz to see if this is the right career for you.
Work Values
Which values are the most important to a person’s satisfaction for this job?
You are someone who is results oriented. You prefer work that allows you to utilize your skills and abilities while at the same time giving you a sense of accomplishment.
You are someone who values job security, steady employment, and good working conditions. You also prefer work that keeps you busy all the time with something different to do every day.
You are someone who values job advancement and leadership roles. You prefer work that receives recognition for the work you do and jobs that are looked up to by others in the company and your community.
You are someone who likes to provide a service to others. You prefer a work environment where you can work with your co-workers in a friendly non-competitive environment.
You are someone who values a company that stands behind their employees. You prefer a work environment where everyone is treated fairly and is being supported by the company.
You are someone who likes to work on your own and make your own decisions. You prefer work that requires little supervision and are allowed to try out your own ideas.
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