{"id":99801,"date":"2024-09-21T17:34:21","date_gmt":"2024-09-21T21:34:21","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/gms\/?page_id=99801"},"modified":"2026-07-27T10:45:40","modified_gmt":"2026-07-27T14:45:40","slug":"regulatory-affairs-ethics-compliance","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/gms\/students\/professional-development\/career-exploration-transition\/regulatory-affairs-ethics-compliance\/","title":{"rendered":"Regulatory Affairs, Ethics, Compliance"},"content":{"rendered":"<h3><strong>Introductory Resources<\/strong><\/h3>\n<ul>\n<li><a href=\"https:\/\/www.raps.org\/Who-We-Are\/About-the-Regulatory-Profession\" target=\"_blank\" rel=\"noopener noreferrer\">What is Regulatory Affairs?<\/a>, Regulatory Affairs Professional Society (RAPS).<\/li>\n<li><a href=\"https:\/\/www.science.org\/content\/article\/research-regulatory-affairs-long-journey-complete-life-cycle\" target=\"_blank\" rel=\"noopener noreferrer\">Career Story &#8211; From the bench to regulatory affairs<\/a>, Science.<\/li>\n<li><a href=\"https:\/\/www.science.org\/content\/article\/day-life-scientific-regulatory-affairs-manager\" target=\"_blank\" rel=\"noopener noreferrer\">A day in the life of a scientific regulatory manager<\/a>, Science.<\/li>\n<li><a href=\"https:\/\/www.youtube.com\/watch?v=7NJEMR9e7d8\" target=\"_blank\" rel=\"noopener noreferrer\">Why working in regulatory means seeing the big picture<\/a>, 6-min video.<\/li>\n<li>Exploring jobs (general job description, skills, etc.), BU Vault:\n<ul>\n<li><a href=\"https:\/\/bu.vault.com\/professions\/regulatory-affairs-managers\" target=\"_blank\" rel=\"noopener noreferrer\">Regulatory Affairs Managers<\/a>.<\/li>\n<li><a href=\"https:\/\/bu.vault.com\/professions\/regulatory-affairs-specialists\" target=\"_blank\" rel=\"noopener noreferrer\">Regulatory Affairs Specialists<\/a>.<\/li>\n<li><a href=\"https:\/\/bu.vault.com\/professions\/compliance-managers\" target=\"_blank\" rel=\"noopener noreferrer\">Compliance Managers<\/a>.<\/li>\n<li><a href=\"https:\/\/bu.vault.com\/professions\/technology-ethicists\" target=\"_blank\" rel=\"noopener noreferrer\">Technical Ethicists<\/a>.<\/li>\n<li><a href=\"https:\/\/bu.vault.com\/professions\/medical-ethicists\" target=\"_blank\" rel=\"noopener noreferrer\">Medical Ethicists<\/a>.<\/li>\n<\/ul>\n<\/li>\n<li><a href=\"https:\/\/bostonuniversity.candidcareer.com\/videos\/manager-of-scientific-and-regulatory-affairs-american-frozen-food-institute\/\" target=\"_blank\" rel=\"noopener noreferrer\">Manager of Scientific and Regulatory Affairs video interview<\/a>, Candid Career.<\/li>\n<li><a href=\"https:\/\/bostonuniversity.candidcareer.com\/videos\/senior-manager-of-regulatory-compliance-verizon-communications\/\" target=\"_blank\" rel=\"noopener noreferrer\">Senior Manager of Regulatory Compliance video interview<\/a>, Candid Career.<\/li>\n<\/ul>\n<h3><strong>Venturing further in this career area<\/strong><\/h3>\n<ul>\n<li><a href=\"https:\/\/rapsprod.blob.core.windows.net\/rapsk13\/raps\/media\/news-images\/feature%20pdf%20files\/21-4_dimichele.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">The PhD Scientists Pathway into Regulatory Affairs<\/a>, Laura DiMichele, PhD, RAC, CCRP.<\/li>\n<li><a href=\"https:\/\/graduate.northeastern.edu\/resources\/working-in-regulatory-affairs-careers-and-trends\/\" target=\"_blank\" rel=\"noopener noreferrer\">Working in Regulatory Affairs &#8211; Roles, Career progression, Salaries, Trends<\/a>, Northeastern University.<\/li>\n<li>Learn more about <a href=\"https:\/\/www.raps.org\/career-and-resources\/research-reports\/regulatory-competency-framework.html\" target=\"_blank\" rel=\"noopener noreferrer\">Regulatory Core Competencies with these RAPS reports<\/a>.<\/li>\n<li><a href=\"https:\/\/www.youtube.com\/watch?v=zz358OaQkeI\" target=\"_blank\" rel=\"noopener\">CMC Considerations for Biotechnology Product Development: A Regulatory Perspective<\/a>, Wendy Weinberg, PhD (FDA, 1-hour YouTube video).<\/li>\n<\/ul>\n<h3><strong>Learning by doing job-related tasks<\/strong><\/h3>\n<p>Job Simulations are job-related tasks that can be completed in a few hours, to help you assess how enjoyable and how much of a good fit a specific job could be for you. <a href=\"https:\/\/intersectjobsims.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Intersect Job Simulations<\/a> have been created by PhDs for PhDs, to support their career transitions into a wide range of careers. To make the most of job simulations, please set up <a href=\"https:\/\/intersectjobsims.com\/smart\/\" target=\"_blank\" rel=\"noopener noreferrer\">SMART Goals<\/a> to perform each simulation in a reasonable timeline. When you have completed the task, fill out the <a href=\"https:\/\/intersectjobsims.com\/reflection\/\" target=\"_blank\" rel=\"noopener noreferrer\">Self-Reflection Sheet<\/a>, which will help you reflect on what you enjoyed (or did not enjoy) about the simulation, and how it can help inform your career exploration efforts.<\/p>\n<ul>\n<li>Regulatory Affairs <a href=\"https:\/\/intersectjobsims.com\/library\/performing-a-competitive-analysis\/\" target=\"_blank\" rel=\"noopener noreferrer\">Job Simulation &#8211; Performing a Competitive Analysis<\/a>.<\/li>\n<li>Explore <a href=\"https:\/\/regardd.org\/videos\" target=\"_blank\" rel=\"noopener noreferrer\">regulatory training videos from ReGARDD<\/a> (Regulatory Guidance for Academic Research of Drugs and Devices).<\/li>\n<li>The <a href=\"https:\/\/medschool.duke.edu\/research\/research-support\/research-support-offices\/office-regulatory-affairs-and-quality\/oraq\" target=\"_blank\" rel=\"noopener noreferrer\">Duke University School of Medicine ORAQ provides education and training<\/a> to people interested in learning more about FDA regulations and ways to transition into Regulatory Affairs roles. They also provided <a href=\"https:\/\/www.youtube.com\/@dukemedschool\/search?query=ORAQ\" target=\"_blank\" rel=\"noopener noreferrer\">recordings of past ORAQ webinars and events on YouTube<\/a>.<\/li>\n<\/ul>\n<h3><strong>Preparing your transition into this career area<br \/>\n<\/strong><\/h3>\n<ul>\n<li><a href=\"https:\/\/www.nature.com\/articles\/d41586-019-01332-1\" target=\"_blank\" rel=\"noopener noreferrer\">Focus on your skills<\/a>, Nature article.<\/li>\n<li>Explore fellowship programs supporting career transitions into regulatory affairs:\n<ul>\n<li><a href=\"https:\/\/hmcrs.org\/fellowship\/apply\/\" target=\"_blank\" rel=\"noopener noreferrer\">Regulatory Affairs Fellowship<\/a>, Harvard MIT Center for Regulatory Science.<\/li>\n<li>Companies like Vertex, GSK, as well as the Food and Drug Administration (<a href=\"https:\/\/www.fda.gov\/about-fda\/center-drug-evaluation-and-research-cder\/regulatory-pharmaceutical-fellowship-program\" target=\"_blank\" rel=\"noopener noreferrer\">FDA Regulatory Pharmaceutical Fellowship<\/a>) have fellowships to help PhD and\/or MD graduates transition into a regulatory affairs career.<\/li>\n<\/ul>\n<\/li>\n<li>Explore and connect with members of the following professional societies:\n<ul>\n<li><a href=\"https:\/\/www.raps.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">Regulatory Affairs Professional Society<\/a>, RAPS.<\/li>\n<li><a href=\"https:\/\/www.topra.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">The Organization for Professional in Regulatory Affairs<\/a>, TOPRA.<\/li>\n<\/ul>\n<\/li>\n<li>Growing your network and <a href=\"https:\/\/intersectjobsims.com\/infointerviewguide\/\" target=\"_blank\" rel=\"noopener noreferrer\">having informational interviews<\/a> with PhDs who have transitioned into careers of interest to you will enable you to learn more about the job&#8217;s daily responsibilities, hiring process, career progression, etc., and the sector as a whole.\n<ul>\n<li>Look for and join relevant thematic groups on LinkedIn, online communities, etc.<\/li>\n<li>Look for <a href=\"https:\/\/www.bumc.bu.edu\/gms\/students\/professional-development\/connect-mentors\/\" target=\"_blank\" rel=\"noopener\">BU Mentors and Alumni<\/a> who have transitioned into this career area.<\/li>\n<li><a href=\"https:\/\/thesocialscientist.org\/\" target=\"_blank\" rel=\"noopener\">The Social Scientist<\/a> enables early-career researchers to connect with folks who have transitioned in various career areas, including in communication and outreach.<\/li>\n<\/ul>\n<\/li>\n<li><a href=\"https:\/\/mymedia.bu.edu\/playlist\/dedicated\/207936103\/1_9emp2sqk\/1_2lldbf4b\" target=\"_blank\" rel=\"noopener noreferrer\">Analyze job descriptions<\/a> to learn more about what institutions and organizations are currently looking for.<\/li>\n<li>Study company websites, follow them on social media and YouTube, and join Regulatory Affairs networks on LinkedIn (e.g., <a href=\"https:\/\/www.linkedin.com\/company\/sdran\/\" target=\"_blank\" rel=\"noopener noreferrer\">San Diego Regulatory Affairs Network)<\/a>.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Introductory Resources What is Regulatory Affairs?, Regulatory Affairs Professional Society (RAPS). Career Story &#8211; From the bench to regulatory affairs, Science. A day in the life of a scientific regulatory manager, Science. Why working in regulatory means seeing the big picture, 6-min video. Exploring jobs (general job description, skills, etc.), BU Vault: Regulatory Affairs Managers. [&hellip;]<\/p>\n","protected":false},"author":20577,"featured_media":0,"parent":99331,"menu_order":16,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/pages\/99801"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/users\/20577"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/comments?post=99801"}],"version-history":[{"count":6,"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/pages\/99801\/revisions"}],"predecessor-version":[{"id":108842,"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/pages\/99801\/revisions\/108842"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/pages\/99331"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/gms\/wp-json\/wp\/v2\/media?parent=99801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}