[Regulatory work] is a big part of the solution to major public health and food safety challenges.”. All medical technologies, including medical equipment, implanted devices, and biotechnological advancements, are also subject to federal and international regulation to ensure their safety, efficacy, and performance. Department of DRA aims to provide a comprehensive education and skills in the important aspects of Regulatory Compliance in the pharmaceutical industry … According to the 2018 report, 51.5 percent of regulatory professionals have worldwide responsibilities, and the number is likely to keep growing due to an increasing number of interconnected global regulations. REGULATORY AFFAIRS : Regulatory Affairs Professionals Responsibility The regulatory professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. Companies in regulated industries are beginning to focus on the use of social media to market products. Along with the promise of job security, pursuing a career in regulatory affairs affords you a great deal of flexibility in where you choose to work. To learn more about advancing your regulatory career, download our free guide below. The lobbying framework should clearly and unambiguously define what is lobbying and who is to be considered a lobbyist and lobbying target for the purposes of regulation. Currently working in Dublin, Michael Mageean started out writing for Belfast-based “Fortnight” magazine in 1998. December 23, 2020. In fact, 25 cents of every dollar spent by American consumers go toward a product or service regulated by the Food and Drug Administration (FDA). In-Demand Biotechnology Careers Shaping Our Future, The Benefits of Online Learning: 7 Advantages of Online Degrees, How to Write a Statement of Purpose for Graduate School, Online Learning Tips, Strategies & Advice, The 3 Most Important Business Skills for Scientists, How to Create a Requirements Management Plan, 360 Huntington Ave., Boston, Massachusetts 02115. Successful regulatory affairs professionals typically have cross-functional training in areas such as science, pharmacy, engineering, marketing, and business. Regulatory projects are usually complex, time-constrained, cross-functional, and resource-intensive. 2.0 SCOPE The guideline shall be applicable for preparation of dossier for ROW market. Regulatory Affairs within the biomedical and health products sector is a relatively young, multidimensional profession that is international in scope. The Scope of Regulatory Affairs in the Pharmaceutical Industry SubashPhilip and Ansa Philip The regulation of medical products has been expanding since early 20th century. The regulation of products in industries such as healthcare, biotechnology, food, industrial chemical and agrochemical is of international concern. Explore Northeastern’s first international campus in Canada’s high-tech hub. With so many options, regulatory professionals can choose to work in organizations of any size, ranging from 10 to 10,000 employees. Because the field of global regulatory affairs spans a diverse set of disciplines, including law, economics, public policy, health, and science, the scope of a regulatory professional’s work varies. According to the 2018 RAPS report, more than 99 percent of regulatory professionals hold a university-level degree, and 44 percent of regulatory professionals hold a master’s degree. To be effective, it needs to know all regulatory requirements and tests thoroughly. Regulatory affairs professionals are employed in industry, government, and in academic research and clinical institutions. One of the most common titles in the industry is regulatory affairs specialist. In terms of career progression, regulatory affairs officers might look to progress to more senior managerial roles (although there might not be much scope for promotion in smaller companies with only one or two regulatory specialists) or to specialise in certain areas. Regulatory Affairs. The Organisation for Professionals in Regulatory Affairs explains on its website that a regulatory affairs department ensures that the firm adheres to state and federal laws protecting public health. Regulatory professionals are also often a voice in conversations at the cutting edge of health and public policy. At Northeastern, graduate students have access to a global network of more than 3,000 employer partners and 230,000 active alumni, who work at leading biotech companies and global brands such as Pfizer, Biogen, Sanofi Genzyme, Boston Scientific, Merck, Kellogg’s, United Airlines, and Coca-Cola.

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