Regulatory Affairs Managers
Also called: Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Affairs Director, Regulatory Affairs Manager
Produced by CareerOneStop
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Regulatory affairs managers and compliance managers keep organizations and products on the right side of rules and requirements, so that the public good is protected. Much of their work involves reviewing data, writing reports and applications, and communicating with teams whether it’s to comply with laws concerning labor, advertising, protecting the environment, consumer privacy, or public safety and health. These managers provide guidance to departments and project teams all the way from the design phase through development and marketing of the final product. Staying on track with regulations takes multiple checks and balances, including managing audits and inspections by regulatory groups such as the Food and Drug Administration, Consumer Product Safety Commission, and others. If a product has a flaw, these compliance professionals oversee the product recall. In order to enter the field, a bachelor’s degree related to the industry is a must, along with several years of job experience. Keeping up to date on new regulations and rules is expected. Typical work settings for these managers are in industries with substantial regulatory obligations, including medical equipment manufacturers, pharmaceutical companies, packaging, utilities, financial services, and chemical manufacturing. A typical work week is 40 hours plus.
What they do:Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
On the job, you would:
- 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.
Arts and Humanities
Safety and Government
People and Technology Systems
Ideas and Logic
People interested in this work like activities that include leading, making decisions, and business.
They do well at jobs that need:
You might use software like this on the job:
Document management software
Data base user interface and query software
See more details at O*NET OnLine about regulatory affairs managers.