What Does A Regulatory Affairs Manager Do (including Their Typical Day at Work)

Stan T.Career, OverviewLeave a Comment

Salary, Job Description, How To Become One, and Quiz

Regulatory Affairs Managers

Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Salary
$75620
Becoming One
Hard
Education
Bachelor's degree
Job Satisfaction
Job Growth

Personality





Find a job you love and you will never work a day in your life.Confucius

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.

Featured Schools


What is the job like

Job satisfaction

Very High

Is this job meaningful

High

75% said they were satisfied with their job and 62% said they found their job meaningful.


Tiffany Drummond, MS
Icahn School of Medicine

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

$75620 per year

Average hourly wage

$36 per hour

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

What is the work day like

Working hours

Less than 40 hours
0%

40 hours
18%

More than 40 hours
82%

Working schedule

82%

18%

0%

Email

How often do you use email in this job?

Once a week
0%

Every day
100%

Telephone

How often do you have telephone conversations in this job?

Once a week
7%

Every day
93%

Group discussions

How often do you have group discussions in this job?

Once a week
15%

Every day
85%

Public speaking

How often does this job require you to do public speaking?

Never
4%

Once a year
61%

Once a month
25%

Once a week
7%

Every day
4%

Level of competition

How much competitive pressure is in this job?

Not competitive at all
4%

Slightly competitive
7%

Moderately competitive
50%

Highly competitive
29%

Extremely competitive
11%

What is the work environment like

Office-style environment

Indoors in an environmentally controlled condition

Never
4%

Once a year or more
0%

Once a month or more
4%

Once a week or more
0%

Every day
93%

Warehouse-style environment

Indoors in a non-controlled environmental condition such as a warehouse

Never
64%

Once a year or more
29%

Once a month or more
7%

Once a week or more
0%

Every day
0%

Outdoors

Outdoors exposed to all weather conditions

Never
89%

Once a year or more
7%

Once a month or more
4%

Once a week or more
0%

Every day
0%

Outdoors – Under Cover

Outdoors but under cover (e.g. structure with roof but no walls)

Never
89%

Once a year or more
11%

Once a month or more
0%

Once a week or more
0%

Every day
0%

How to become one

Difficulty to become one

Hard
You will need a considerable amount of work-related skill, knowledge, or experience. Careers in this difficulty category usually require a Bachelor’s degree and several years of work-related experience, on-the-job training, and/or vocational training. Similar careers include Database Administrators, Chemists, Art Directors, and Accountants.

Required level of education

What level of education do you need to perform the job?

Less than a High School Diploma
0%

High School Diploma or equivalent
0%

Post-Secondary Certificate
0%

Some College Courses
0%

Associate’s Degree or similar
4%

Bachelor’s Degree
75%

Post-Baccalaureate Certificate
0%

Master’s Degree
14%

Post-Master’s Certificate
4%

First Professional Degree
4%

Doctoral Degree
0%

Post-Doctoral Training
0%

Relevant majors

No majors found

Relevant work experience

How much related work experience do you need to get hired for the job?

None
0%

1 month
0%

1 to 3 months
0%

3 to 6 months
0%

6 months to 1 year
0%

1 to 2 years
4%

2 to 4 years
32%

4 to 6 years
32%

6 to 8 years
11%

8 to 10 years
14%

Over 10 years
7%

On The Job Training

How much on the job training do you need to perform the job?

None or short demonstration
11%

1 month
7%

1 to 3 months
11%

3 to 6 months
21%

6 months to 1 year
14%

1 to 2 years
18%

2 to 4 years
4%

4 to 10 years
11%

Over 10 years
4%

Should you become one

Best personality type for this career

The Leader

People with this personality likes to start and work on projects. They also like leading people and making many decisions.

The Builder
24%

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.


The Thinker
29%

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.


The Artist
24%

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.


The Helper
48%

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.


The Leader
100%

People with The Leader personality likes to start and work on projects. They also like leading people and making many decisions.


The Organizer
76%

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?

Achievement
71%

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.

Working Conditions
67%

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.

Recognition
62%

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.

Relationships
62%

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.

Support
67%

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.

Independence
71%

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.

FAQ


Don’t know which career to pursue?

Take the career quiz to find careers that match your personality type.

Take The Career Quiz


Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.