Oxford Global Resources is seeking a Global CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma company to support headquarters in Barcelona through our consulting services division.Key ResponsibilitiesProvide CMC regulatory insight and advice to multidisciplinary teams, as well as CMC technical functions on CMC/Quality regulations and guidelines according to the Agencies expectations for successful approvals.Provide significant contribution or leading efforts for the authoring of CMC documents for the submission to Health Authorities (HA), including MAA preparation, post?approval variations and responses to HA questions,



as well as IMPDs for products under development.Coordinate any CMC regulatory activity required to expand the company portfolio in different territories (e.Collaborate in the assessment of Business Development opportunities in relation to CMC topics.Ensure compliance with integral regulatory requirements and contribute to the development of internal global standard operating procedures and guidance documents as needed.Establish good collaboration and interactions across various functions and teams, such as manufacturing sites (CMOs), Quality Assurance, supply chain, etc.Fluency in English for business communication.Minimum 5 years in Regulatory CMC field for pharmaceutical products, ideally at a global level.Knowledge of regulatory frameworks for medical devices and food supplements desirable.timeJob functionScience, Research, and Project ManagementIndustriesPharmaceutical Manufacturing, Biotechnology Research, and Business Consulting and ServicesLocation:

📌 Regulatory Affairs Manager (España)
🏢 Oxford Global Resources
📍 España