Regulatory Affairs Senior Specialist

2 weeks ago

City of Westminster, United Kingdom Wipro Technologies Full time

ResponsibilitiesHas overall accountability for the initial creation and relevant updates to labeling documentsGuiding the labeling team to develop and maintain Core Date sheets, USPI, SmPC and associated Patient Labeling documents along with regulatory authority driven documents such as Core Safety ProfileThe lead needs to be updated with labeling guidelines and regulations pertaining to the development / maintenance of US and EU labelingShould be knowledgeable on key labeling requirements worldwide, in order to ensure that CDS updates may be implemented globally. The lead will review the downstream impact of CDS updates on Local Product Documents (LPDs) and ensure that downstream impact on LPDs is considered during Labeling Team discussionsProvides project management to the Labeling team throughout the entire process, from the decision making to updates in CDS / USPI / SPCAct as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirementsFacilitate cross-functional and team awareness and understanding of regulatory issues as appropriateContribute to local or global system and process improvementsQualifications4-6 years of experience in the Pharma or Medical Devices industrySignificant hands‑on registration experience associated with development, maintenance, and commercialization activities within Regulatory affairsUnderstand regulatory implications of product strategy with regards to the product label & assessmentAbility to interpret and apply global and local regulatory guidance around labeling and associated supportive documentationExcellent written and verbal communication skillsProven strength in logical, analytical and writing abilityDemonstrate project management skills and attention to detailGood to have skills :Proven understanding of the dynamics and purpose of CDS; experiences of review and implications of CDSPrior experience with biologicalsBenefits & OpportunitiesOpportunity to work in a fast‑growing company and in a multinational environment for some of the biggest brands in the world.Potential for career growth within the organization and the opportunity to build a successful career path.Flexible and fully remote work environment, allowing you to work from the comfort of your home in any city in Europe.Access to a diverse range of benefits.Personal and professional development through a variety of training programs covering both hard and soft skills.Comprehensive salary package with various components.Complex reward and recognition schemes (both non‑monetary and monetary options). #J-18808-Ljbffr

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