{"id":30349,"date":"2025-11-07T10:35:08","date_gmt":"2025-11-07T09:35:08","guid":{"rendered":"https:\/\/sidler-sa.ch\/?post_type=job_listing&#038;p=30349"},"modified":"2025-12-23T00:51:01","modified_gmt":"2025-12-22T23:51:01","slug":"regulatory-affairs-specialist-lugano","status":"expired","type":"job_listing","link":"https:\/\/sidler-sa.ch\/en?post_type=job_listing&p=30349","title":{"rendered":"REGULATORY AFFAIRS SPECIALIST \/ LUGANO"},"content":{"rendered":"<p class=\"s7\"><em><strong><span class=\"s6\">Duties<\/span><span class=\"s6\"> and <\/span><span class=\"s6\">responsibilities<\/span><span class=\"s6\">:<\/span><\/strong><\/em><\/p>\n<ul>\n<li class=\"s11\"><span class=\"s9\">Prepare, compile, and submit regulatory documentation for product registration, renewals, and variations in accordance with\u00a0<\/span><span class=\"s10\">Swissmedic<\/span><span class=\"s9\">,\u00a0<\/span><span class=\"s10\">EMA<\/span><span class=\"s9\">, and\u00a0<\/span><span class=\"s10\">FDA<\/span><span class=\"s9\"> requirements.<br \/>\n<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Ensure<\/span> <span class=\"s9\">ongoing<\/span><span class=\"s9\"> compliance of <\/span><span class=\"s9\">product<\/span><span class=\"s9\"> dossiers <\/span><span class=\"s9\">with<\/span><span class=\"s9\"> relevant <\/span><span class=\"s9\">pharmaceutical<\/span> <span class=\"s9\">regulations<\/span><span class=\"s9\"> and <\/span><span class=\"s9\">internal<\/span> <span class=\"s9\">quality<\/span><span class=\"s9\"> standards.<br \/>\n<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Monitor and <\/span><span class=\"s9\">interpret<\/span> <span class=\"s9\">regulatory<\/span><span class=\"s9\"> changes at local and global <\/span><span class=\"s9\">levels<\/span><span class=\"s9\">, <\/span><span class=\"s9\">assessing<\/span> <span class=\"s9\">their<\/span><span class=\"s9\"> impact on <\/span><span class=\"s9\">company<\/span> <span class=\"s9\">operations<\/span><span class=\"s9\"> and <\/span><span class=\"s9\">products<\/span><span class=\"s9\">.<br \/>\n<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Support cross-<\/span><span class=\"s9\">functional<\/span> <span class=\"s9\">teams<\/span><span class=\"s9\"> (<\/span><span class=\"s9\">Quality<\/span><span class=\"s9\"> Assurance, R&amp;D, <\/span><span class=\"s9\">Manufacturing<\/span><span class=\"s9\">, <\/span><span class=\"s9\">Supply<\/span><span class=\"s9\"> Chain) in <\/span><span class=\"s9\">regulatory<\/span><span class=\"s9\"> aspects <\/span><span class=\"s9\">throughout<\/span><span class=\"s9\"> the <\/span><span class=\"s9\">product<\/span> <span class=\"s9\">lifecycle<\/span><span class=\"s9\">.<br \/>\n<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Maintain<\/span><span class=\"s9\"> up-to-date <\/span><span class=\"s9\">knowledge<\/span><span class=\"s9\"> of <\/span><span class=\"s9\">pharmaceutical<\/span> <span class=\"s9\">legislation<\/span><span class=\"s9\">, guidelines, and best practices.<br \/>\n<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Liaise<\/span> <span class=\"s9\">with<\/span> <span class=\"s9\">health<\/span> <span class=\"s9\">authorities<\/span><span class=\"s9\"> and <\/span><span class=\"s9\">regulatory<\/span> <span class=\"s9\">agencies<\/span><span class=\"s9\"> as <\/span><span class=\"s9\">needed<\/span><span class=\"s9\">.<br \/>\n<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Contribute<\/span><span class=\"s9\"> to <\/span><span class=\"s9\">internal<\/span><span class=\"s9\"> audits and <\/span><span class=\"s9\">regulatory<\/span><span class=\"s9\"> inspections.<\/span><\/li>\n<\/ul>\n<p class=\"s7\"><em><strong><span class=\"s6\">The <\/span><span class=\"s6\">ideal<\/span><span class=\"s6\"> candidate <\/span><span class=\"s6\">will<\/span><span class=\"s6\"> have the <\/span><span class=\"s6\">following<\/span> <span class=\"s6\">skills<\/span><span class=\"s6\">, <\/span><span class=\"s6\">knowledges<\/span><span class=\"s6\"> and <\/span><span class=\"s6\">experience<\/span><span class=\"s6\">:<\/span><\/strong><\/em><\/p>\n<ul>\n<li class=\"s11\"><span class=\"s9\">Bachelor\u2019s<\/span><span class=\"s9\"> or <\/span><span class=\"s9\">Master\u2019s<\/span> <span class=\"s9\">degree<\/span><span class=\"s9\"> in\u00a0<\/span><span class=\"s10\">Pharmacy<\/span><span class=\"s10\">, Chemistry, Life Sciences, or <\/span><span class=\"s10\">related<\/span> <span class=\"s10\">field<\/span><span class=\"s9\">.<\/span><\/li>\n<li class=\"s11\"><span class=\"s8\">\u00a0<\/span><span class=\"s10\">2<\/span><span class=\"s10\">\u2013<\/span><span class=\"s10\">3<\/span> <span class=\"s10\">years<\/span><span class=\"s10\"> of <\/span><span class=\"s10\">experience<\/span><span class=\"s9\">\u00a0in <\/span><span class=\"s9\">Regulatory<\/span> <span class=\"s9\">Affairs<\/span> <span class=\"s9\">within<\/span><span class=\"s9\"> the\u00a0<\/span><span class=\"s10\">pharmaceutical<\/span> <span class=\"s10\">industry<\/span><span class=\"s9\">, <\/span><span class=\"s9\">gained<\/span><span class=\"s9\"> in <\/span><span class=\"s9\">Switzerland<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Solid <\/span><span class=\"s9\">knowledge<\/span><span class=\"s9\"> of\u00a0<\/span><span class=\"s10\">EU and <\/span><span class=\"s10\">Swiss<\/span> <span class=\"s10\">pharmaceutical<\/span> <span class=\"s10\">regulations<\/span><span class=\"s9\">\u00a0(<\/span><span class=\"s9\">Swissmedic<\/span><span class=\"s9\">, EMA, FDA <\/span><span class=\"s9\">knowledge<\/span> <span class=\"s9\">is<\/span><span class=\"s9\"> an asset).<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Experience<\/span><span class=\"s9\"> in <\/span><span class=\"s9\">preparing<\/span><span class=\"s9\"> and <\/span><span class=\"s9\">maintaining<\/span><span class=\"s9\">\u00a0<\/span><span class=\"s10\">CTD\/<\/span><span class=\"s10\">eCTD<\/span><span class=\"s9\">\u00a0dossiers.<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Strong communication and <\/span><span class=\"s9\">organizational<\/span> <span class=\"s9\">skills<\/span> <span class=\"s9\">with<\/span><span class=\"s9\"> excellent attention to <\/span><span class=\"s9\">detail<\/span><span class=\"s9\">.<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Fluent in <\/span><span class=\"s10\">English<\/span><span class=\"s9\">\u00a0(<\/span><span class=\"s9\">written<\/span><span class=\"s9\"> and <\/span><span class=\"s9\">spoken<\/span><span class=\"s9\">);<\/span><span class=\"s9\">\u00a0<\/span><span class=\"s10\">Italian<\/span><span class=\"s10\"> and\/or German<\/span><span class=\"s9\">\u00a0<\/span><span class=\"s9\">is<\/span><span class=\"s9\"> a plus.<\/span><\/li>\n<li class=\"s11\"><span class=\"s9\">Ability to work independently and collaboratively in a fast-paced environment.<\/span><\/li>\n<\/ul>\n","protected":false},"author":165,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"a.terrana@sidler-sa.ch","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":"","_job_grid_image":"","is_private":"0","_job_desc":"","_job_level":"","_job_experience":"","_job_company_name":"sidler-corporate","_job_content":"","_custom_apply_link":"0","_apply_link_type":"","_apply_link_text":"","_apply_link_email":"","_apply_form_link":""},"job-categories":[],"job-types":[149],"ctrljm_skill":[84,83,82],"job_listing_tag":[],"class_list":{"0":"post-30349","1":"job_listing","2":"type-job_listing","3":"status-expired","4":"hentry","5":"ctrljm_skill-de","6":"ctrljm_skill-en","7":"ctrljm_skill-it","8":"no-post-thumbnail","9":"pt-10","11":"job-type-corporate"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/job-listings\/30349","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/users\/165"}],"wp:attachment":[{"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/media?parent=30349"}],"wp:term":[{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/job-categories?post=30349"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/job-types?post=30349"},{"taxonomy":"ctrljm_skill","embeddable":true,"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/ctrljm_skill?post=30349"},{"taxonomy":"job_listing_tag","embeddable":true,"href":"https:\/\/sidler-sa.ch\/en\/wp-json\/wp\/v2\/job_listing_tag?post=30349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}