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"Regulatory Affairs Manager"
Job Description - Part 1 - Duties and Tasks

Basic Job Description:

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Part 1
Duties / Tasks
Part 2
Part 3
Part 4
Part 5


Job Duties and Tasks for: "Regulatory Affairs Manager"

1) Provide responses to regulatory agencies regarding product information or issues.

2) Train staff in regulatory policies or procedures.


3) Coordinate internal discoveries and depositions with legal department staff.

4) Develop and maintain standard operating procedures or local working practices.

5) Establish regulatory priorities or budgets and allocate resources and workloads.


6) Maintain current knowledge of relevant regulations, including proposed and final rules.

7) Manage activities such as audits, regulatory agency inspections, or product recalls.

8) Participate in the development or implementation of clinical trial protocols.

9) Direct the preparation and submission of regulatory agency applications, reports, or correspondence.

10) Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

11) Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

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12) Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.

13) Develop regulatory strategies and implementation plans for the preparation and submission of new products.

14) Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.


15) Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

16) Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

17) Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.

18) Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.

19) Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.

20) Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.

21) Contribute to the development or implementation of business unit strategic and operating plans.

22) Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.

23) Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.

24) Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.

25) Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.

26) Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.

27) Monitor regulatory affairs trends that are related to environmental issues.

Job Description for "Regulatory Affairs Manager" continued here...

Part 1
Duties / Tasks
Part 2
Part 3
Part 4
Part 5

"Regulatory Affairs Manager"   Holland / RIASEC Career Code:  NA        SOC:  11-9199.01


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