Manager Regulatory Affairs Labelling Strategist

Company DescriptionSmartedge Solutions, established in 2005 and headquartered in London, is a globally recognized technology firm with 15 offices worldwide. The company specializes in IT services and Professional Recruitment Services (PRS) across Europe. Smartedge is known for its expertise in the IT and engineering domains, leveraging a network of highly skilled consultants and a comprehensive database of over 100,000 professionals. With a commitment to delivering innovative and competitive solutions, Smartedge is dedicated to enhancing organizational performance and driving growth for its clients.Role DescriptionJob Details : Role Name : Manager Regulatory Affairs-Labelling StrategistRole type: Contract (B-B contract)   Role Location: Remote  Job Description :Responsible for the review, development, and maintenance of pharmaceutical product labeling to ensure compliance with global regulatory requirements, internal standards, and market needs. This includes managing updates to labeling content, coordinating cross-functional input, and supporting product launches and lifecycle changes. Key Responsibilities:Label Content Management:Review and update product labels, cartons, and inserts in accordance with FDA, EMA, CDSCO, and other global regulatory requirements.Ensure labeling reflects accurate product information including indications, contraindications, dosage, warnings, and usage instructions.Regulatory Compliance:Monitor changes in labeling regulations and assess impact on existing products.Conduct gap assessments and develop remediation plans to maintain compliance.Cross-Functional Collaboration:Work with Regulatory Affairs, Quality, Marketing, Legal, and Manufacturing teams to gather input and finalize labeling content.Lead or support labeling-related projects such as new product launches, market expansions, or regulatory updates.Documentation and Systems:Maintain labeling records in electronic document management systems (e.g., Veeva Vault, SmartSolve).Initiate and manage Change Control documentation for labeling updates.Quality and Process Improvement:Support audits and inspections by providing labeling documentation and ensuring traceability.Contribute to the development and revision of SOPs related to labeling processes. Qualifications:Bachelor’s degree in pharmacy, Life Sciences, or related field.Experience in pharmaceutical labeling or regulatory affairs.Strong understanding of global labeling regulations (FDA, EU MDR, CDSCO).Proficiency in Microsoft Office and labeling software (e.g., Adobe InDesign, BarTender).Excellent attention to detail, communication, and project management skills. Preferred Skills:Experience with global labeling strategy and CCDS (Company Core Data Sheet) development.Familiarity with UDI (Unique Device Identification) and GS1 standards.Technical writing and proofreading skills.Ability to work independently and manage multiple projects under tight deadlines. ------------------------Thanks & Regards,