{"id":479643,"date":"2026-05-12T14:38:38","date_gmt":"2026-05-12T12:38:38","guid":{"rendered":"https:\/\/astekjob.fr\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/"},"modified":"2026-05-25T19:09:57","modified_gmt":"2026-05-25T17:09:57","slug":"technical-regulatory-cmc-writer-waterloo-belgium-f-m","status":"publish","type":"job_listing","link":"https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/","title":{"rendered":"Technical Regulatory CMC Writer &#8211; Waterloo, Belgium  (F\/M)"},"content":{"rendered":"<p><span style=\"color: rgba(65, 168, 95, 1)\"><strong>What we will accomplish together:<\/strong><\/span><\/p>\n<p>Alsinova is looking on <strong>a regular basis for Technical Regulatory CMC Writers<\/strong> to join our consulting team for clients&#8217; projects (from big pharma to small biotech) based in <strong>Belgium.<\/strong><\/p>\n<p><span style=\"color: rgba(65, 168, 95, 1)\"><strong>Your mission (should you decide to accept it):<\/strong><\/span><\/p>\n<p>Your potential challenges will be various, depending on the clients&#8217; priorities. The list below gives you examples of our classic activities.<\/p>\n<p><span style=\"color: rgba(65, 168, 95, 1)\"><strong>Your daily activities will be:<\/strong><\/span><\/p>\n<ul>\n<li>The Technical Regulatory Writer is involved in the company\u2019s regulatory activities related to new &#038; existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions&#8230;.<\/li>\n<li>Write CMC, \u201cfacility and equipment\u201d parts and new files for WW regulatory File.<\/li>\n<li>Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the\u00a0writing\/review process to ensure timely completion.<\/li>\n<li>Ensure the coordination with the departments involved in the writing\/review process.<\/li>\n<li>Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities.<\/li>\n<li>Monitor that supportive data provided by other departments are compliant.<\/li>\n<li>Report significant issues.<\/li>\n<li>Manage the projects within all company\/GRA tracking tools.<\/li>\n<li>Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change\u00a0controls impacting both CMC and facilities.<\/li>\n<\/ul>\n<ul>\n<li>Good communication skills.<\/li>\n<li>Writing skills.<\/li>\n<li>Analytical skills, creative and critical mind.<\/li>\n<li>Ensures the coherence between contributions \/ quality of final results.<\/li>\n<li>Team player.<\/li>\n<\/ul>\n<p><span style=\"color: rgba(65, 168, 95, 1)\"><strong>You:<\/strong><\/span><\/p>\n<ul>\n<li>University level (Life Sciences background is preferred) or equivalent by experience.<\/li>\n<\/ul>\n<ul>\n<li>At least 3 years of experience in writing CMC (technical) parts of regulatory documents (registration files or variations).<\/li>\n<li>Experience working in validation\/QA\/production in Biologics\/Pharmaceuticals industry.<\/li>\n<li>Knowledge of regulatory procedures \/ systems \/ guidance.<\/li>\n<li>Knowledge of biologic process and process equipment.<\/li>\n<li>Knowledge of Qualification \/ Validation principles.<\/li>\n<li>Manages own time to meet agreed short-term targets.<\/li>\n<li>Microsoft.<\/li>\n<li>PowerPoint &#038; Excel.<\/li>\n<\/ul>\n<ul>\n<li>French.<\/li>\n<li>Good level of spoken and written English.<\/li>\n<\/ul>\n<ul>\n<li>Good communication skills.<\/li>\n<li>Writing skills.<\/li>\n<li>Analytical skills, creative and critical mind.<\/li>\n<li>Ensures the coherence between contributions \/ quality of final results.<\/li>\n<li>Team player.<\/li>\n<\/ul>\n<p>Alsinova<\/p>\n<p><strong>Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. <\/strong>Alsinova offers a complete CRO solution, providing innovative, customised solutions in various life science segments: pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary and healthcare institutions.<\/p>\n<p>Alsinova is the subsidiary of the Astek Group,<strong> a global player in engineering and technology consulting.<\/strong> Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its <strong>10 000 employees<\/strong> who are committed every day to promoting combination of digital technologies and complex systems engineering.<\/p>\n<p><strong>Join a Group rapidly developing in France and around the world, with a turnover of 705 M\u20ac in 2024.<\/strong><\/p>\n<p>More on the Group on our websites https:\/\/alsinova.com and https:\/\/astek.net.<\/p>\n<p><strong>Astek is committed to the employment of people with disabilities.<\/strong><\/p>\n<p><strong>Our benefits<\/strong><\/p>\n<p>Joining Astek means choosing:<\/p>\n<ul>\n<li>an experience accelerator, where every assignment is an opportunity to progress<\/li>\n<li>access to a multitude of technically exciting projects for our clients as well as internally<\/li>\n<li>individualized, local support for a tailored career path<\/li>\n<li>continuous learning, thanks to our internal training academy<\/li>\n<li>a friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practices<\/li>\n<\/ul>\n<p><strong>Let&#8217;s move forward.<\/strong>\u00a0<\/p>\n","protected":false},"author":0,"featured_media":0,"template":"","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_promoted":"","_job_location":"Waterloo","_application":"Jayani.brooks@alsinova.com","_company_name":"Alsinova","_company_website":"https:\/\/alsinova.com","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[1562],"job-types":[1434],"class_list":{"0":"post-479643","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"hentry","6":"job-type-full-time-job"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Technical Regulatory CMC Writer - Waterloo, Belgium (F\/M) - Astekjob<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Technical Regulatory CMC Writer - Waterloo, Belgium (F\/M) - Astekjob\" \/>\n<meta property=\"og:description\" content=\"What we will accomplish together: Alsinova is looking on a regular basis for Technical Regulatory CMC Writers to join our consulting team for clients&#8217; projects (from big pharma to small biotech) based in Belgium. Your mission (should you decide to accept it): Your potential challenges will be various, depending on the clients&#8217; priorities. The list [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/\" \/>\n<meta property=\"og:site_name\" content=\"Astekjob\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-25T17:09:57+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/job\\\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\\\/\",\"url\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/job\\\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\\\/\",\"name\":\"Technical Regulatory CMC Writer - Waterloo, Belgium (F\\\/M) - Astekjob\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/#website\"},\"datePublished\":\"2026-05-12T12:38:38+00:00\",\"dateModified\":\"2026-05-25T17:09:57+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/job\\\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/astekjob.fr\\\/en\\\/job\\\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/job\\\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Technical Regulatory CMC Writer &#8211; Waterloo, Belgium (F\\\/M)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/\",\"name\":\"Astekjob\",\"description\":\"Le site de recrutement du Groupe Astek\",\"publisher\":{\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/#organization\"},\"alternateName\":\"Astekjob\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/#organization\",\"name\":\"Groupe Astek\",\"url\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/astekjob.fr\\\/wp-content\\\/uploads\\\/2021\\\/11\\\/Astek-Group_Hor_Officiel.png\",\"contentUrl\":\"https:\\\/\\\/astekjob.fr\\\/wp-content\\\/uploads\\\/2021\\\/11\\\/Astek-Group_Hor_Officiel.png\",\"width\":1215,\"height\":307,\"caption\":\"Groupe Astek\"},\"image\":{\"@id\":\"https:\\\/\\\/astekjob.fr\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/company\\\/astek\\\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Technical Regulatory CMC Writer - Waterloo, Belgium (F\/M) - Astekjob","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:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/","og_locale":"en_US","og_type":"article","og_title":"Technical Regulatory CMC Writer - Waterloo, Belgium (F\/M) - Astekjob","og_description":"What we will accomplish together: Alsinova is looking on a regular basis for Technical Regulatory CMC Writers to join our consulting team for clients&#8217; projects (from big pharma to small biotech) based in Belgium. Your mission (should you decide to accept it): Your potential challenges will be various, depending on the clients&#8217; priorities. The list [&hellip;]","og_url":"https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/","og_site_name":"Astekjob","article_modified_time":"2026-05-25T17:09:57+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/","url":"https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/","name":"Technical Regulatory CMC Writer - Waterloo, Belgium (F\/M) - Astekjob","isPartOf":{"@id":"https:\/\/astekjob.fr\/en\/#website"},"datePublished":"2026-05-12T12:38:38+00:00","dateModified":"2026-05-25T17:09:57+00:00","breadcrumb":{"@id":"https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/astekjob.fr\/en\/job\/technical-regulatory-cmc-writer-waterloo-belgium-f-m\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/astekjob.fr\/en\/"},{"@type":"ListItem","position":2,"name":"Technical Regulatory CMC Writer &#8211; Waterloo, Belgium (F\/M)"}]},{"@type":"WebSite","@id":"https:\/\/astekjob.fr\/en\/#website","url":"https:\/\/astekjob.fr\/en\/","name":"Astekjob","description":"Le site de recrutement du Groupe Astek","publisher":{"@id":"https:\/\/astekjob.fr\/en\/#organization"},"alternateName":"Astekjob","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/astekjob.fr\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/astekjob.fr\/en\/#organization","name":"Groupe Astek","url":"https:\/\/astekjob.fr\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/astekjob.fr\/en\/#\/schema\/logo\/image\/","url":"https:\/\/astekjob.fr\/wp-content\/uploads\/2021\/11\/Astek-Group_Hor_Officiel.png","contentUrl":"https:\/\/astekjob.fr\/wp-content\/uploads\/2021\/11\/Astek-Group_Hor_Officiel.png","width":1215,"height":307,"caption":"Groupe Astek"},"image":{"@id":"https:\/\/astekjob.fr\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/astek\/"]}]}},"_links":{"self":[{"href":"https:\/\/astekjob.fr\/en\/wp-json\/wp\/v2\/job-listings\/479643","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/astekjob.fr\/en\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/astekjob.fr\/en\/wp-json\/wp\/v2\/types\/job_listing"}],"wp:attachment":[{"href":"https:\/\/astekjob.fr\/en\/wp-json\/wp\/v2\/media?parent=479643"}],"wp:term":[{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/astekjob.fr\/en\/wp-json\/wp\/v2\/job-categories?post=479643"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/astekjob.fr\/en\/wp-json\/wp\/v2\/job-types?post=479643"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}