Senior Regulatory Labeling Lead — Remote

ResponsibilitiesHas overall accountability for the initial creation and relevant updates to labeling documentsGuiding the labeling team to develop and maintain Core Date sheets, USPI, SmPC and associated Patient Labeling documents along with regulatory authority driven documents such as Core Safety ProfileThe lead needs to be updated with labeling guidelines...

Responsibilities Preparation of labeling content based on source documents such as CSRs, regulatory requirements and other reference documents. Review worldwide labeling against the Core Company Safety Information and facilitate and track implementation of Core Labeling changes. Assist with the management of CCDSs. Document control and distribution of...

A global biopharmaceutical company in London seeks a professional with substantial experience in Regulatory Affairs for a full-time role. The candidate will be responsible for managing labeling projects, reviewing labeling documents, and ensuring compliance with regulatory requirements. A degree in life sciences and experience in US and EU labeling are...

Job DescriptionGeneral Summary:The Senior Director, Regulatory Strategy International (EU Affiliates & ROW), is responsible for regulatory strategy, team management, and the execution of local submission strategies in their respective markets. International markets comprise those outside North America, which includes the European  Affiliates (EU, UK, and...

A leading life sciences recruiter is seeking a Regulatory Executive Senior to develop and manage CMC regulatory strategies. This remote position involves ensuring compliance with global guidelines and effectively managing multiple projects. Candidates must have expertise in regulatory submissions, risk assessment, and strong communication skills. Join to...

Job DescriptionGeneral Summary:The Senior Director, Regulatory Strategy, Rest of World (ROW) is responsible for regulatory strategy and execution of submissions in the ROW region, including the planning and coordinating of complex regulatory submissions, e.g., MAAs and new therapeutic indications, and will also represent RA on multidisciplinary teams. ROW is...

Job DescriptionGeneral Summary:The International Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring...

A global medical products company is looking for a Solution Owner R&D (Regulatory & Quality) to oversee R&D-related management systems while ensuring compliance and operational needs. The ideal candidate should have 7–8 years of experience in IT systems, specialization in regulatory solutions, and strong problem-solving skills. This position offers remote...

Work from anywhere and shape powerful regulatory strategies that drive results! Enjoy the freedom of remote work while making a global impact. Proclinical is seeking a Regulatory Executive Senior to manage and accelerate global Chemistry, Manufacturing, and Controls (CMC) regulatory marketing applications and early lifecycle activities. In this role, you...

Senior Director, Regulatory Affairs – CMC, Regulatory Operations & Lifecycle Management Join Perrigo Company plc as Senior Director, Regulatory Affairs – CMC, Regulatory Operations & Lifecycle Management. At Perrigo, we are driven by our mission to make lives better through trusted health and wellness solutions, accessible to all. We are proud to be a...