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

Job Description

Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. They also provide responses to regulatory agencies regarding product information or issues.

Other tasks include:

• 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.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Maintain current knowledge of relevant regulations, including proposed and final rules.

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

75% of them said they were satisfied with their job and 62% 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 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 design, development, evaluation, or marketing of products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

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

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 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.

Working life

More than 40 hours per week

Regular schedule like a 9 to 5

In a typical work week as a Regulatory Affairs Manager, you can expect to work more than 40 hours per week.

Is this right for me

People who are suitable for this job tends 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.

You can read more about these career personality types here.

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