SOURCE: Regulatory Affairs Professional Society
RAPS has released a new white paper, Regulatory Affairs Professional Development Framework: An Overview, which describes the knowledge, skills and abilities of regulatory professionals. This is the first report of its kind to be published. Download the white paper: http://www.raps.org/pdFramework/WhitePaper
Regulatory affairs is a dynamic and challenging profession that is vital to making safe and effective healthcare products available worldwide. Regulatory Affairs encompasses a variety of disciplines and job responsibilities, which may begin during the product development and continue into when a product is widely available for use.
Individuals who ensure regulatory compliance and prepare submissions as well as those whose main job function is clinical affairs or quality assurance are all considered Regulatory Affairs professionals.
Regulatory Affairs professionals are employed in industry, government and academia and are involved with a wide range of products, including: pharmaceuticals,medical devices,in vitro diagnostics,biologics and biotechnology,nutritional products,cosmetics and veterinary products. The professionals' roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post-market surveillance.
Core Competencies
Regulatory Affairs professionals come from diverse backgrounds. Most Regulatory Affairs professionals have earned a bachelor's degree, and over half have an advanced degree, most often in a scientific or technical field. Regulatory Affairs professionals usually have experience in other careers before transitioning into regulatory affairs. Often, they have worked in the fields of medicine, nursing, pharmacy, engineering, clinical laboratory science, research or healthcare manufacturing.
Although some university degrees and graduate certificates are being developed, experience is a key asset for Regulatory Affairs professionals. Other valuable skills include project management/organizational skills, negotiation and communication skills and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the Regulatory affairs professional. Regulatory Affairs professionals must keep up-to-date with regulatory policies and procedures for one or more countries as well as maintain an understanding of the scientific and technical background of products. Many Regulatory Affairs professionals seek opportunities to expand their business-related skills, including project management, communication and financial management.
Individuals who ensure regulatory compliance and prepare submissions as well as those whose main job function is clinical affairs or quality assurance are all considered Regulatory Affairs professionals.
Regulatory Affairs professionals are employed in industry, government and academia and are involved with a wide range of products, including: pharmaceuticals,medical devices,in vitro diagnostics,biologics and biotechnology,nutritional products,cosmetics and veterinary products. The professionals' roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post-market surveillance.
Core Competencies
Regulatory Affairs professionals come from diverse backgrounds. Most Regulatory Affairs professionals have earned a bachelor's degree, and over half have an advanced degree, most often in a scientific or technical field. Regulatory Affairs professionals usually have experience in other careers before transitioning into regulatory affairs. Often, they have worked in the fields of medicine, nursing, pharmacy, engineering, clinical laboratory science, research or healthcare manufacturing.
Although some university degrees and graduate certificates are being developed, experience is a key asset for Regulatory Affairs professionals. Other valuable skills include project management/organizational skills, negotiation and communication skills and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the Regulatory affairs professional. Regulatory Affairs professionals must keep up-to-date with regulatory policies and procedures for one or more countries as well as maintain an understanding of the scientific and technical background of products. Many Regulatory Affairs professionals seek opportunities to expand their business-related skills, including project management, communication and financial management.
2 comments:
hi varun i appreciate ur efforts to enhance our knowledge about regulatory affairs . ur posts r really worthy n insightful for those who r new in this field. just keep going !!!!!!!!!
Thanks Kalpana,If you are intersted in joining this Programe just log on to www.bii.in before 30th june 2008 or please read the presentation available on the blog.
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