In Summary - Regulatory Affairs Manager
Regulatory Affairs Managers typically work in the following Career Sectors:
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The Work - Regulatory Affairs Manager
Most commonly reported Work Tasks
- 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.
Most commonly reported Work Activities
- Evaluating Information to Determine Compliance with Standards Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
- Getting Information Observing, receiving, and otherwise obtaining information from all relevant sources.
- Communicating with Supervisors, Peers, or Subordinates Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
- Communicating with Persons Outside Organization Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
- Updating and Using Relevant Knowledge Keeping up-to-date technically and applying new knowledge to your job.
- Organizing, Planning, and Prioritizing Work Developing specific goals and plans to prioritize, organize, and accomplish your work.
- Establishing and Maintaining Interpersonal Relationships Developing constructive and cooperative working relationships with others, and maintaining them over time.
- Making Decisions and Solving Problems Analyzing information and evaluating results to choose the best solution and solve problems.
- Documenting/Recording Information Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
- Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
Interests - Regulatory Affairs Manager
This occupation is typically suited for people with the following Career Interests:
The Investigative person will usually find a particular area of science to be of interest. They are inclined toward intellectual and analytical activities and enjoy observation and theory. They may prefer thought to action, and enjoy the challenge of solving problems with sophiscticated technology. These types prefer mentally stimulating environments and often pay close attention to developments in their chosen field.
Enterprising people like situations that involve using resources for personal or corporate economic gain. Such people may have an opportunistic frame of mind, and are drawn to commerce, trade and making deals. Some pursue sales and marketing occupations. Many will eventually end up owning their own business, or in management roles in larger organisations. They tend to be very goal-oriented and work best when focused on a target. Some have an entrepreneurial inclination.
Administrative people are interested in work that offers security and a sense of being part of a larger process. They may be at their most productive under supervisors who give clear guidelines and while performing routine tasks in a methodical and reliable way.
They tend to enjoy clerical and most forms of office work, where they perform essential administrative duties. They often form the backbone of large and small organisations alike. They may enjoy being in charge of office filing systems, and using computers and other office equipment to keep things running smoothly. They usually like routine work hours and prefer comfortable indoor workplaces.
Entry Requirements - Regulatory Affairs Manager
Relevant degree areas include life, physical, mathematical, applied and medical sciences in areas such as:
- The life sciences
- Medicinal chemistry
- Biomedical science
- Chemical and physical sciences
The College of Science, School of Natural Sciences at NUIG offer an MSc. in Medical Technology Regulatory Affairs.
Last Updated: August, 2015
Pay & Salary - Regulatory Affairs Manager
Salary Range (thousands per year)* 63k - 78k
Last Updated: March, 2017
* The lower figures typically reflect starting salaries. Higher salaries are awarded to those with greater experience and responsibility. Positions in Dublin sometimes command higher salaries.