{"id":14575,"date":"2024-09-24T10:15:10","date_gmt":"2024-09-24T14:15:10","guid":{"rendered":"https:\/\/www.blackdiamondnet.com\/jobs\/eu-hybrid-sr-regulatory-manager-235836\/"},"modified":"2024-11-05T14:04:22","modified_gmt":"2024-11-05T19:04:22","slug":"eu-hybrid-sr-regulatory-manager-235836","status":"publish","type":"jobs","link":"https:\/\/www.blackdiamondnet.com\/fr\/jobs\/eu-hybrid-sr-regulatory-manager-235836\/","title":{"rendered":"EU (Hybrid): Sr. Regulatory Manager (235836)"},"content":{"rendered":"<p><span style=\"text-decoration: underline;\"><strong>Responsibilities:<\/strong><\/span><\/p>\n<ul>\n<li>Develop\/contribute\/review content and format according to country regulatory guidelines for regulatory submissions (major and minor submissions, PSURs, MSSRs etc.), Swissmedic meeting requests, variations, notifications and other regulatory activities.<\/li>\n<li>Work with Global Regulatory Science and Global cross-functional project teams regarding the development and execution of regulatory strategy through the clinical development processes to post-market activity.<\/li>\n<li>Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.<\/li>\n<li>Contact regulatory agencies relevant to assigned projects or programs, as appropriate.<\/li>\n<li>Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (CTA through commercial).<\/li>\n<li>Maintain Swiss labelling (SmPC, PIL, artwork and packaging) in alignment with regulatory requirements and Global labeling\/core-datasheet.<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Skills:<\/strong><\/span><\/p>\n<ul>\n<li>BA\/BS degree in a scientific\/engineering\/healthcare discipline required, Masters, PharmD or PhD preferred.<\/li>\n<li>5-8+ years of experience in Regulatory Affairs or related field<\/li>\n<li>Experience in biologics, vaccines essential, Rare or Autoimmune Diseases and Oncology is preferred<\/li>\n<li>Strong knowledge of current Swissmedic regulations, eCTD and EMA or other international regulatory processes.<\/li>\n<li>Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. Strong experience with CTD format and eCTD submission builds, including preparation of Module 1 documents<\/li>\n<li>Proven ability to liaise with Regulatory Agencies<\/li>\n<li>Excellent command of spoken and written German and English languages is a must.<\/li>\n<li>Experience with developing and implementing gap analysis and related competitive regulatory strategies<\/li>\n<li>Advanced problem-solving ability and a drive to generate compliant regulatory solutions prior to elevation of topics to manager<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>EU (Hybrid): Sr. Regulatory Manager (235836)<\/p>\n<p>#LI-Hybrid<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EU (Hybrid): Sr. Regulatory Manager (235836) Develop\/contribute\/review content and format according to country regulatory guidelines for regulatory submissions (major and minor submissions, PSURs, MSSRs etc.), Swissmedic meeting requests, variations, notifications and other regulatory activities. Work with Global Regulatory Science and Global cross-functional project teams regarding the development and execution of regulatory strategy through the clinical development processes to post-market activity.<\/p>\n","protected":false},"featured_media":0,"template":"","tags":[],"service_area":[368],"location":[527],"job_status":[594],"class_list":["post-14575","jobs","type-jobs","status-publish","hentry","service_area-sciences-de-la-vie-et-technologie","location-leurope","job_status-closed-fr"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-07-28 06:39:05","action":"category","newStatus":"draft","terms":[585],"taxonomy":"job_status","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/jobs\/14575","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/jobs"}],"about":[{"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/types\/jobs"}],"wp:attachment":[{"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/media?parent=14575"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/tags?post=14575"},{"taxonomy":"service_area","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/service_area?post=14575"},{"taxonomy":"location","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/location?post=14575"},{"taxonomy":"job_status","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/job_status?post=14575"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}