What Do Regulatory Affairs Specialists Do (including Their Typical Day At Work)

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Job Description, Daily Responsibilities, and Work Life

Regulatory Affairs Specialists

Regulatory Affairs Specialists coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

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

Personality
Interest Match



Job Description

Job Description

Regulatory Affairs Specialists coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies. They also coordinate efforts associated with the preparation of regulatory documents or submissions.

Other tasks include:

  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

We asked Regulatory Affairs Specialists how satisfied they are with their job. Here is what they said.

Job satisfaction

70%

How meaningful is this job

47%


70% of them said they were satisfied with their job and 47% said they find that their job makes the world a better place or helps to make someone else’s life better.



Typical Day At Work

On a daily basis, Regulatory Affairs Specialists compile and maintain regulatory documentation databases or systems. They coordinate efforts associated with the preparation of regulatory documents or submissions.

A typical day for a Regulatory Affairs Specialist will also include:

  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.

We asked some Regulatory Affairs Specialists a few questions to find out what else does their work day look like. Here is what we found.

Do you have telephone conversations everyday in this job? 73% said yes
How important is it to work in a team in this job? 52% said very important
Do you have group discussions everyday in this job? 67% said yes
Do you talk or work with customers everyday in this job? 18% said yes
Do you have to deal with angry customers everyday in this job? 0% said yes
Do you have to make decisions everyday in this job? 27% said yes

Other responsibilities

Besides their typical day, Regulatory Affairs Specialists also maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. They may also communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

On a weekly to monthly basis, Regulatory Affairs Specialists Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. They might also Identify relevant guidance documents, international standards, or consensus standards.

In addition, they Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

Although specific duties may vary, many of them Prepare or maintain technical files as necessary to obtain and sustain product approval.

To some Regulatory Affairs Specialists, it is also their responsibility to Recommend adjudication of product complaints.


Working life

Working hours

Standard 40 hour work week

Working schedule

Regular schedule like a 9 to 5

In a typical work week as a Regulatory Affairs Specialist, you can expect to work 40 hour work week.

Do Regulatory Affairs Specialists work in an office-style work environment?

Every day
79%


Never
5%


Do Regulatory Affairs Specialists work outdoors?

Never
95%


Once a year
5%



Is this right for me

Best personality for this career

The Organizers and The Entrepreneurs

People who are suitable for this job tends to like following set procedures and routines. They like working with data and details more than with ideas..

They also 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.

You can read more about these career personality types here.



Learn more about Regulatory Affairs Specialists

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