What Do Regulatory Affairs Associates Do: Job Description, Responsibilities and Duties

Stanley TanLeave a Comment



daily life of a Regulatory Affairs Specialist
are Regulatory Affairs Specialists happy with their job

Regulatory Affairs Specialists

Other names for this job might include Clinical Quality Assurance Associate, Clinical Quality Assurance Specialist, Drug Regulatory Affairs Specialist, Product Safety Specialist, Quality Assurance Documentation Coordinator, Quality Assurance Documentation Specialist, Quality Assurance Specialist, Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist), Regulatory Affairs Analyst, Regulatory Affairs Associate


  • $69180
    Salary
  • 70%
    Job satisfaction
  • Quite Hard
    Becoming one
  • Low
    Job growth
OwlGuru Rank

B



Being A Regulatory Affairs Associate: What You Really Do


In this job description guide, you will find out what do Regulatory Affairs Specialists do and what is their typical work day like.

After reading this, you will have a much better idea on whether you will like working as a Regulatory Affairs Specialist or not.



Job summary

Regulatory Affairs Associates 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.

We asked Regulatory Affairs Associates 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.



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Typical day

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On a daily basis, Regulatory Affairs Associates Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. They Compile and maintain regulatory documentation databases or systems.

1 of the main responsibilities as A Regulatory Affairs Associate is to Coordinate efforts associated with the preparation of regulatory documents or submissions.

Some may also Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

A typical day for A Regulatory Affairs Associate look like this:

Explain regulations, policies, or procedures.
Maintain data in information systems or databases.
Coordinate regulatory documentation activities.

We asked some Regulatory Affairs Associates 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
Do you have to use email everyday in this job?97% 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 have to meet strict deadlines everyday in this job?21% 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 the “typical day” things that Regulatory Affairs Associates do, they Analyze product complaints and make recommendations regarding their reportability. They might also Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

On a weekly to monthly basis, Regulatory Affairs Associates Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. and 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.

Although specific duties may vary, many of them Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.

To some Regulatory Affairs Associates, it is also their responsibility to Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

Coordinate regulatory documentation activities.Examine product information to ensure compliance with regulations.Advise others on legal or regulatory compliance matters.Evaluate applicable laws and regulations to determine impact on organizational activities.


Working life

Working hours

More than 40 hours per week

Working schedule

Regular (Set schedule and routine)


In a typical work week as A Regulatory Affairs Associate, you can expect to work More than 40 hours per week.

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

Everyday
69.7%

Once a week
12.12%

Once a month
0%

Once a year
3.03%

Never
15.15%

Do Regulatory Affairs Associates work in a warehouse-style work environment?

Everyday
6.06%

Once a week
0%

Once a month
3.03%

Once a year
15.15%

Never
75.76%

Do Regulatory Affairs Associates work outdoors?

Everyday
3.03%

Once a week
0%

Once a month
0%

Once a year
3.03%

Never
93.94%



Is this right for me

Best personality for this career

The Organizers and The Persuaders


You can read more about these career personality types here.

You will like this career if you are someone who likes following set procedures and routines. They like working with data and details more than with ideas.

You 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.



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Green New & Emerging
Governmental and Regulatory Administration
Administration and Administrative Support

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Related to Regulatory Affairs Specialists Job Description

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Additional resources

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Regulatory Affairs Specialists
Written by: Stanley Tan
Regulatory Affairs Associates 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.
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