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Regulatory Affairs Manager

Academic programs / Undergraduate degrees / Career opportunities / Regulatory Affairs Manager

Regulatory Affairs Manager

Explore employment trends, required job duties and skills for this career. ASU offers a variety of degrees that can help you prepare for and meet your career goals. Visit ASU's Career and Professional Development Services to learn how to develop your career plan.

Potential job titles in this career
CMC Director (Chemistry, Manufacturing, and Controls Director), Compliance Director, Global RA Director (Global Regulatory Affairs Director), Global RA Manager (Global Regulatory Affairs Manager), RA Director (Regulatory Affairs Director), RA Manager (Regulatory Affairs Manager), RA QA Director (Regulatory Affairs Quality Assurance Director), RA VP (Regulatory Affairs Vice President), Regulatory Director, Vaccine RA Director (Vaccine Regulatory Affairs Director)

* Additional schooling, certification, or degrees maybe be required for some of the potential careers that are listed.
What will I do?
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • In this career, it is important to know
    English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, and rules of composition and grammar.

    Law and Government - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.

    Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

    Biology - Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.

    Education and Training - Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.

    Administrative - Knowledge of administrative and office procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and workplace terminology.

    Chemistry - Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.

    Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

    Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.

    Medicine and Dentistry - Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
    It's useful to be good at
    Written Expression - The ability to communicate information and ideas in writing so others will understand.

    Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.

    Oral Expression - The ability to communicate information and ideas in speaking so others will understand.

    Written Comprehension - The ability to read and understand information and ideas presented in writing.

    Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.

    Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).

    Near Vision - The ability to see details at close range (within a few feet of the observer).

    Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing that there is a problem.

    Speech Clarity - The ability to speak clearly so others can understand you.

    Speech Recognition - The ability to identify and understand the speech of another person.
    Employment trends
    Location Pay period 2024
    10% 25% Median% 75% 90%
    United States Hourly $33.11 $48.08 $65.65 $86.15 $109.42
    Yearly $68,860 $100,010 $136,550 $179,190 $227,590
    Arizona Hourly $40.44 $50.52 $63.48 $81.14 $103.10
    Yearly $84,120 $105,080 $132,040 $168,760 $214,450
    2024 Median%
    United States $65.65 Hourly $136,550 Yearly
    Arizona $63.48 Hourly $132,040 Yearly

    Employment (2024)
    1,333,700 employees
    Projected growth (2024 - 2034)
    Average (4% to 7%)
    Projected job openings (2024 - 2034)
    106,700
    * Data obtained from the Occupational Information Network (O*NET) under sponsorship of the U.S. Department of Labor/Employment and Training Administration (USDOL/ETA).
    What are accelerated programs?
    Accelerated programs allow students the opportunity to expedite the completion of their degree.

    Accelerated master's

    These programs allow students to accelerate their studies to earn a bachelor's plus a master's degree in as few as five years (for some programs).

    Each program has requirements students must meet to be eligible for consideration. Students typically receive approval to pursue the accelerated master’s during the junior year of their bachelor's degree program. Interested students can learn about eligibility requirements and how to apply.
    What are concurrent programs?
    Concurrent degrees allow students to pursue their own personal or professional interests, earn two distinct degrees and receive two diplomas. To add a concurrent degree to your existing degree, work with your academic advisor.
    What are joint programs?
    Joint programs, or jointly conferred degrees, are offered by more than one college and provide opportunities for students to take advantage of the academic strengths of two academic units. Upon graduation, students are awarded one degree and one diploma conferred by two colleges.

    What constitutes a new program?
    ASU adds new programs to Degree Search frequently. Come back often and look for the “New Programs” option.
    What are online programs?
    ASU Online offers programs in an entirely online format with multiple enrollment sessions throughout the year. See https://asuonline.asu.edu/ for more information.
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