Regulatory Affairs Managers

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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

  • Pharmaceutical Quality Assurance Manager
  • Quality Assurance Director
  • Quality Assurance Supervisor
  • Regulatory Administrator
  • Regulatory Affairs Director
  • Regulatory Affairs Manager
  • Regulatory Process Manager

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.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • 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.
  • Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • 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.
  • Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
  • Coordination - Adjusting actions in relation to others' actions.

Education Required

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

LMI Region

Wages

In 2013, the average annual wage in United States was $108,380 with most people making between $53,880 and $164,560

Outlook

0.72%
avg. annual growth

During 2010, this occupation employed approximately 828,000 people in United States. It is projected that there will be 893,000 employed in 2020.

This occupation will have about 6,000 openings due to growth and about 243,000 replacement openings for approximately 249,000 total annual openings.

Common College Majors