Regulatory affairs manager állások, munkák

• Lifecycle management of approved regulatory files
• Documentation support in registration and renewal procedures
• Preparation of ASMF/DMF/CEP according to project timelines, ensuring compliance with regulatory requirements and facilitating submissions to the Authorities

• Acting as a specialist within the team
• Acquiring marketing authorizations for medicines in line with SOPs, WIs, and relevant regulatory guidelines
• Maintaining existing marketing authorizations according to market specific requirements and internal procedures

Project planning and execution: assist in the development and management of project plans for regulatory remediation efforts, including scope, timelines, resources, and deliverables...

• Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization.
• Serve as primary EU regulatory contact for cross-functional teams and provide clear, actionable regulatory guidance while ensuring compliance with regulatory requirements

Responsibility for the sustainable and timely certification and approvals of devices across four Business Units—particularly in the areas of diamond drilling and cutting, dust management, measuring and fastening tools with various drive systems, robotics, as well as wireless and IT products...

General Counsel - Lausanne/Prilly Malley or Zurich (Switzerland) About Salt Salt Mobile is one of Switzerland’s leading telecommunications providers, delivering innovative mobile, internet, and TV solutions to consumers and businesses across the country. We are seeking an experienced and...

In the role as _Global Head of Regulatory Affairs_, you lead a global organization of approximately 80 regulatory professionals across CMC Regulatory and Regulatory Affairs and drive regulatory strategies for the established product portfolio, focusing on product integration, lifecycle management,...

Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior...

You maintain and continuously enhance our quality management system and process landscape with a clear focus on BSI C5 compliance and ISO 9001....

• Ensuring compliance with applicable medical device software regulations and standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366 and IVDR
• Defining, maintaining, and governing software-related quality policies, procedures, SOPs, templates and lifecycle frameworks

• Ensure flawless and timely reporting processes.
• You take care of the plausibility check, control and documentation of the regulatory reporting process.
• Be responsible for statistical and financial regulatory reports of N26 Bank and Group.