Regulatory Affairs Managers

Bookmark Print History Journal
x

Journal


    • Please sign in to view journal entries
x

Your Employment History in this Occupation

Please sign in to view Employment History
x
Rating
x

Please fill out the fields below to e-mail someone a link to this page

x
Please sign in to bookmark occupations

About the Job

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

It is also Called

  • Clinical Trials Systems Administrator
  • Global Regulatory Affairs Manager
  • Global Regulatory Affairs Vice President
  • Regulatory Administrator
  • Regulatory Affairs Director
  • Regulatory Affairs Manager
  • Regulatory Affairs Portfolio Leader
  • Regulatory Consultant
  • Regulatory Leader
  • Regulatory Process Manager
View All

What They Do

  • 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.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

Interests

People who work in this occupation generally have the interest code: EC.

This means people who work in this occupation generally have Enterprising interests, but also prefer Conventional environments.

Work Values

People who work in this occupation generally prize Achievement, but also value Independence and Working Conditions in their jobs.

Things They Need to Know

  • Law and Government - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
  • English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
  • 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.
  • 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.

Things They Need to Be Able to Do

  • Reading Comprehension - Understanding written sentences and paragraphs in work related documents.
  • Speaking - Talking to others to convey information effectively.
  • Writing - Communicating effectively in writing as appropriate for the needs of the audience.
  • Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
  • Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
  • Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • Monitoring - Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

Education Required

Most of these occupations require a four-year bachelor's degree, but some do not.

Wages

In 2018, the average annual wage in Ohio was $107,320 with most people making between $55,610 and $166,520

Outlook

0.70%
avg. annual growth

During 2016, this occupation employed approximately 24,170 people in Ohio. It is projected that there will be 25,860 employed in 2026.

This occupation will have about 169 openings due to growth and about 1,731 replacement openings for approximately 1,900 total annual openings.

Apprenticeship Opportunities

  • John Marshall High School
    3952 WEST 140TH ST
    CLEVELAND, OH 44111

Education & Training