Smartedge’s Client is looking for an individual to help with their CMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation @ Spain (100 % Remote Working)Key area:Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation.Coordinate with manufacturing and quality teams to ensure accurate and timely data for regulatory submissions.Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reportsExperienced in authoring assessment reports and Part2/ Expert reports for DossiersLead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.Manage execution / authoring of CMC documentation (Module 1, 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.Knowledge of regulatory guidelines and relevant applications.Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.If this sounds like a role you would be interested in or if you know someone in this field.Connect with me or email me atAlternatively, you can call me on Tel: +44(0) .