{"id":14551,"date":"2024-09-16T16:17:33","date_gmt":"2024-09-16T20:17:33","guid":{"rendered":"https:\/\/www.blackdiamondnet.com\/?post_type=jobs&#038;p=14551"},"modified":"2024-09-16T16:17:33","modified_gmt":"2024-09-16T20:17:33","slug":"ch-regulatory-clinical-trial-application-consultant-235701","status":"publish","type":"jobs","link":"https:\/\/www.blackdiamondnet.com\/en-uk\/jobs\/ch-regulatory-clinical-trial-application-consultant-235701\/","title":{"rendered":"CH: Regulatory Clinical Trial Application Consultant (235701)"},"content":{"rendered":"<p><span style=\"text-decoration: underline;\"><strong>Duration<\/strong><\/span><\/p>\n<ul>\n<li>6 months or longer<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Job Description<\/strong><\/span><\/p>\n<ul>\n<li>Our Client is seeking a highly skilled and experienced Regulatory Clinical Trial Application Consultant for a contract role. The Regulatory Clinical Trial Application Consultant will play a critical role in supporting the preparation, submission, and management of clinical trial applications to ensure regulatory compliance and facilitate the smooth progression of clinical studies.<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Responsibilities<\/strong><\/span><\/p>\n<ul>\n<li>Clinical Trial Application Preparation: Lead and support the preparation of clinical trial applications (CTAs) and related documents, ensuring they meet regulatory requirements and guidelines.<\/li>\n<li>Submission Management: Coordinate and manage the submission process for clinical trial applications to health authorities and ethics committees. Track submission timelines, respond to regulatory queries, and ensure timely approvals.<\/li>\n<li>Regulatory Compliance: Ensure that all clinical trial activities adhere to applicable regulations and guidelines, including FDA, EMA, and ICH GCP standards. Monitor and update compliance practices as needed.<\/li>\n<li>Documentation Management: Maintain and organize regulatory documents related to clinical trials, including application files, correspondence with regulatory bodies, and compliance records.<\/li>\n<li>Regulatory Strategy: Provide strategic advice on regulatory requirements and processes for clinical trials, including guidance on regulatory pathways and submission strategies.<\/li>\n<li>Vendor Coordination: Work with external vendors and service providers to ensure compliance with regulatory standards and study protocols.<\/li>\n<li>Audit and Inspection Support: Assist with audit and inspection preparations by ensuring all regulatory documentation and processes are in order. Support responses to regulatory inspections and audits.<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Qualifications<\/strong><\/span><\/p>\n<ul>\n<li>Education: Bachelor\u2019s degree in Life Sciences, Pharmacy, or a related field.<\/li>\n<li>Experience: Minimum of 3 years of experience in regulatory affairs, specifically related to clinical trial applications and submissions, within the pharmaceutical or biotechnology industry.<\/li>\n<li>Knowledge: In-depth understanding of regulatory requirements for clinical trials, including FDA, EMA, and ICH GCP standards.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>CH: Regulatory Clinical Trial Application Consultant (235701)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>CH: Regulatory Clinical Trial Application Consultant (235701) In-depth understanding of regulatory requirements for clinical trials, including FDA, EMA, and ICH GCP standards.<\/p>\n","protected":false},"featured_media":0,"template":"","tags":[],"service_area":[40],"location":[190],"job_status":[585],"class_list":["post-14551","jobs","type-jobs","status-publish","hentry","service_area-life-sciences-technology","location-european-union","job_status-closed"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-10-14 10:27:09","action":"category","newStatus":"draft","terms":[585],"taxonomy":"job_status","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.blackdiamondnet.com\/en-uk\/wp-json\/wp\/v2\/jobs\/14551","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.blackdiamondnet.com\/en-uk\/wp-json\/wp\/v2\/jobs"}],"about":[{"href":"https:\/\/www.blackdiamondnet.com\/en-uk\/wp-json\/wp\/v2\/types\/jobs"}],"wp:attachment":[{"href":"https:\/\/www.blackdiamondnet.com\/en-uk\/wp-json\/wp\/v2\/media?parent=14551"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/en-uk\/wp-json\/wp\/v2\/tags?post=14551"},{"taxonomy":"service_area","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/en-uk\/wp-json\/wp\/v2\/service_area?post=14551"},{"taxonomy":"location","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/en-uk\/wp-json\/wp\/v2\/location?post=14551"},{"taxonomy":"job_status","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/en-uk\/wp-json\/wp\/v2\/job_status?post=14551"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}