{"id":127502,"date":"2026-06-10T20:38:49","date_gmt":"2026-06-10T20:38:49","guid":{"rendered":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/"},"modified":"2026-06-11T00:49:54","modified_gmt":"2026-06-11T00:49:54","slug":"lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri","status":"publish","type":"job_listing","link":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/","title":{"rendered":"Senior Regulatory Affairs Specialist"},"content":{"rendered":"<h4><strong><a id=\"myCustomID\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/LSNJN1462134AJ_1781123929\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n<p style=\"font-weight: 400;\">The Senior Regulatory Affairs Specialist&#8217;s responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and support of Regulatory activities including but not limited to:<\/p>\n<ul style=\"font-weight: 400;\">\n<li>Plan\/author\/compile\/submit statutory reports in eCTD format for marketed products per FDA requirements<\/li>\n<li>Review, assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site<\/li>\n<li>Where appropriate, act as the CMC regulatory lead to cross-functional teams and other personnel on health authority requirements and preparation of information\/technical data needed for support of post-approval changes<\/li>\n<li>Author\/compile\/submit post-approval change supplements<\/li>\n<li>Author\/review updates to marketed product labeling<\/li>\n<li>Maintain regulatory knowledge of current guidelines and regulations<\/li>\n<li>Maintain current regulatory databases and produce various reports as needed<\/li>\n<li>Utilize and support electronic document management system<\/li>\n<li>Provides mentorship for entry-level and intermediate-level regulatory associates<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><strong>Essential Functions<\/strong><\/p>\n<ul style=\"font-weight: 400;\">\n<li>Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings.<\/li>\n<li>Understand, identify potential regulatory risks and recommend strategies based on current FDA\/health authority requirements.<\/li>\n<li>Manage multiple priorities.<\/li>\n<li>Attend necessary trainings and seminars to keep abreast of new and\/or changes in the Regulatory profession.<\/li>\n<li>Process, interpret and provide recommendations for complex, unusual issues.<\/li>\n<li>Critically review documentation for regulatory submissions and provide input for necessary revisions.<\/li>\n<li>Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA,EU,HC, TGA, PIC\/S, ISO, USP, NRC, cGMP, etc.).<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><strong>Requirements<\/strong><\/p>\n<ul style=\"font-weight: 400;\">\n<li>Bachelor Degree in scientific discipline required or equivalent work experience.<\/li>\n<li>5 or more years of Regulatory experience or related field. RAC certification preferred.<\/li>\n<li>Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required.<\/li>\n<li>Project leadership or supervisory experience is preferred.<\/li>\n<li>Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.<\/li>\n<li>Excellent written and oral communication skills.<\/li>\n<li>Use of software system to manage change controls.<\/li>\n<li>Strong background using Microsoft Office tools and Adobe Acrobat.<\/li>\n<li>Travel Time Required &#8211; up to 10% (May vary depending on region\/site).<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><strong>Working Conditions:<\/strong><\/p>\n<ul style=\"font-weight: 400;\">\n<li>Standard office environment.<\/li>\n<li>Willingness to work in a team-based environment.<\/li>\n<li>Close attention to detail required.<\/li>\n<li>May be required to sit or stand for long periods of 8+ hours a day while performing duties.<\/li>\n<li>The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.<\/li>\n<\/ul>\n<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/counter.adcourier.com\/bGlmZXNjaWVuY2VzbmpuLjYzOTA0LjEyNTg0QGJlYWNvbmhpbGwuYXBsaXRyYWsuY29t.gif\"><\/p>\n<p><span style=\"color: #ffffff;\">LSNJN1462134AJ_1781123929<\/span><\/p>\n<h4><strong><a id=\"otherId\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/LSNJN1462134AJ_1781123929\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n","protected":false},"author":0,"featured_media":3770,"template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","inline_featured_image":false,"_promoted":"","_job_location":"St. Louis, Missouri","_application":"lifesciencesnjn.63904.12584@beaconhill.aplitrak.com","_company_name":"Beacon Hill Staffing Group","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[213,299,374,311],"job-types":[2,16],"class_list":["post-127502","job_listing","type-job_listing","status-publish","has-post-thumbnail","hentry","job-type-full-time","job-type-temporary-contract"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Senior Regulatory Affairs Specialist St. Louis Missouri<\/title>\n<meta name=\"description\" content=\"Senior Regulatory Affairs Specialist St. Louis Missouri - Apply with Beacon Hill Staffing Services for this Senior Regulatory Affairs Specialist job in St. Louis, Missouri\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Senior Regulatory Affairs Specialist St. Louis Missouri\" \/>\n<meta property=\"og:description\" content=\"Senior Regulatory Affairs Specialist St. Louis Missouri - Apply with Beacon Hill Staffing Services for this Senior Regulatory Affairs Specialist job in St. Louis, Missouri\" \/>\n<meta property=\"og:url\" content=\"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/\" \/>\n<meta property=\"og:site_name\" content=\"Nationwide Staffing Agency | Temp &amp; Permanent Placement | Executive Search | Beacon Hill\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-11T00:49:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/bhsg.com\/jobs\/wp-content\/uploads\/2021\/12\/favicon.png\" \/>\n\t<meta property=\"og:image:width\" content=\"180\" \/>\n\t<meta property=\"og:image:height\" content=\"180\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"Senior Regulatory Affairs Specialist St. Louis Missouri\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Senior Regulatory Affairs Specialist St. Louis Missouri","description":"Senior Regulatory Affairs Specialist St. Louis Missouri - Apply with Beacon Hill Staffing Services for this Senior Regulatory Affairs Specialist job in St. Louis, Missouri","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/","og_locale":"en_US","og_type":"article","og_title":"Senior Regulatory Affairs Specialist St. Louis Missouri","og_description":"Senior Regulatory Affairs Specialist St. Louis Missouri - Apply with Beacon Hill Staffing Services for this Senior Regulatory Affairs Specialist job in St. Louis, Missouri","og_url":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/","og_site_name":"Nationwide Staffing Agency | Temp &amp; Permanent Placement | Executive Search | Beacon Hill","article_modified_time":"2026-06-11T00:49:54+00:00","og_image":[{"width":180,"height":180,"url":"https:\/\/bhsg.com\/jobs\/wp-content\/uploads\/2021\/12\/favicon.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_title":"Senior Regulatory Affairs Specialist St. Louis Missouri","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/","url":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/","name":"Senior Regulatory Affairs Specialist St. Louis Missouri","isPartOf":{"@id":"https:\/\/bhsg.com\/jobs\/#website"},"primaryImageOfPage":{"@id":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/#primaryimage"},"image":{"@id":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/#primaryimage"},"thumbnailUrl":"https:\/\/bhsg.com\/jobs\/wp-content\/uploads\/2021\/12\/favicon.png","datePublished":"2026-06-10T20:38:49+00:00","dateModified":"2026-06-11T00:49:54+00:00","description":"Senior Regulatory Affairs Specialist St. Louis Missouri - Apply with Beacon Hill Staffing Services for this Senior Regulatory Affairs Specialist job in St. Louis, Missouri","breadcrumb":{"@id":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/#primaryimage","url":"https:\/\/bhsg.com\/jobs\/wp-content\/uploads\/2021\/12\/favicon.png","contentUrl":"https:\/\/bhsg.com\/jobs\/wp-content\/uploads\/2021\/12\/favicon.png","width":180,"height":180},{"@type":"BreadcrumbList","@id":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1462134aj_1781123929-senior-regulatory-affairs-specialist-st-louis-missouri\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/bhsg.com\/jobs\/"},{"@type":"ListItem","position":2,"name":"Senior Regulatory Affairs Specialist"}]},{"@type":"WebSite","@id":"https:\/\/bhsg.com\/jobs\/#website","url":"https:\/\/bhsg.com\/jobs\/","name":"Nationwide Staffing Agency | Temp &amp; Permanent Placement | Executive Search | Beacon Hill","description":"Beacon Hill","publisher":{"@id":"https:\/\/bhsg.com\/jobs\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/bhsg.com\/jobs\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/bhsg.com\/jobs\/#organization","name":"Beacon Hill Staffing","url":"https:\/\/bhsg.com\/jobs\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/bhsg.com\/jobs\/#\/schema\/logo\/image\/","url":"https:\/\/jobs.beaconhillstaffing.com\/jobs\/wp-content\/uploads\/2021\/12\/favicon.png","contentUrl":"https:\/\/jobs.beaconhillstaffing.com\/jobs\/wp-content\/uploads\/2021\/12\/favicon.png","width":180,"height":180,"caption":"Beacon Hill Staffing"},"image":{"@id":"https:\/\/bhsg.com\/jobs\/#\/schema\/logo\/image\/"}}]}},"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/bhsg.com\/jobs\/wp-json\/wp\/v2\/job-listings\/127502","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bhsg.com\/jobs\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/bhsg.com\/jobs\/wp-json\/wp\/v2\/types\/job_listing"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bhsg.com\/jobs\/wp-json\/wp\/v2\/media\/3770"}],"wp:attachment":[{"href":"https:\/\/bhsg.com\/jobs\/wp-json\/wp\/v2\/media?parent=127502"}],"wp:term":[{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/bhsg.com\/jobs\/wp-json\/wp\/v2\/job-categories?post=127502"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/bhsg.com\/jobs\/wp-json\/wp\/v2\/job-types?post=127502"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}