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SRG are currently looking for Regulatory Executive for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their office in Weybridge.
The Role:The purpose of this role is to provide regulatory leadership, governance and expertise to one sub-category or a brand or a portfolio of products such that the labelling of existing products is successfully maintained globally.The individual will build a network of collaborative relationships within Global and Regional Regulatory Affairs to ensure the provision of accurate, evidence-based product information to healthcare professionals, patients and/or consumers for existing products.In close collaboration with cross functional teams/stakeholders, the role is accountable for updating the existing Global Data Sheets, creating the supportive documentation to support both approval and local PI implementation and providing Labelling expertise/information in regulatory affairs activities.Key Responsibilities:In collaboration with all and for a sub-category, brand or portfolio of products:Update the Global Data Sheets.Create and revise the supportive documentation required for GDS approval.Present the Global Data Sheets update and supportive documentation for approval.Plan, prepare and deliver high quality regulatory files supporting local submission.Manage country labelling differences and support CLD process.Develop responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders.Ensure compliance.Provide Labelling expertise/information for Regulatory Affairs activities.If applicable,Prepare Global Data Sheets compliance metrics for presentation and complete follow up activity.May act as labelling SME to support successful implementation of Regulatory Information Management systems.Provide training on labelling processes for Global and Regional Regulatory Affairs.Collaborate with Regulatory Affairs Compliance to support continuous improvement of labelling process and direct new policy or pioneer new processes or improvements.May act as company representative to external groups on specific task forces within labelling expertise. Skills/Experience Required:Minimum graduate level, with a relevant biologically based scientific background. Previous labelling experience.Proficiency in speaking, comprehending, reading and writing English.Excellent prioritization and time-management skills.IT literate with proficiency in using word, excel, power point.If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: firstname.lastname@example.org or +441615077288