Regulatory Affairs Manager

Manager Regulatory Affairs – Global Labeling Product LeaderLocation:Brazil (Remote)Type:Full Time | 12 Month Fixed Term Contract (FTC)Start Date:ASAPAbout the Company:Our client is aglobal healthcare leaderspecializing in innovative pharmaceutical and medical products that improve patient outcomes worldwide.With a strong focus on quality, safety, and compliance, the company operates across multiple therapeutic areas and global markets.The successful candidate will join a collaborative Regulatory Affairs organization driving excellence in labeling compliance and product lifecycle management.Position Summary:TheManager Global Labeling Product Leaderis responsible for thedevelopment maintenance and quality oversightof primary and derived product labeling documents across global markets.This position ensures that labeling content is compliant with international regulations and internal quality standards while contributing to global labeling strategy and product lifecycle management.You will act as a key liaison between cross functional teams including Regulatory Affairs Safety Medical and Commercial to deliver consistent compliant and scientifically accurate product information.Key ResponsibilitiesLead thecreation revision and maintenanceof primary and derived labeling documents (for example CCDS USPI SmPC) ensuring alignment with regulatory requirements and company strategy.Collaborate cross functionally withSubject Matter Experts (SMEs)throughLabeling Working Groups (LWG)andLabeling Committees (LC)to gain consensus on labeling content.Develop labeling text supported by clinical preclinical and safety data considering competitor and market context.Ensure the accuracy clarity and scientific integrity of labeling documents through effective data review and documentation traceability.Support the implementation ofglobal labeling strategiesincluding the development of target labeling for new and existing products.Partner withGlobal Regulatory Affairs (GRA)andGlobal Labeling Operations (GLO)to ensure dissemination and alignment of labeling deliverables.Maintain up to date understanding of global labeling regulations (EU US and international) CIOMS guidance and industry best practices.Support audits inspections andCorrective and Preventive Action (CAPA)management related to labeling activities.Contribute tocontinuous improvement initiativesto optimize labeling processes and documentation quality.Provide labeling support and guidance to regional and local operating companies ensuring compliance across markets.Qualifications and ExperienceEssential:Bachelor's degree inLife Sciences Pharmacy or a related discipline.Minimum4 years of experiencein thepharmaceutical or healthcare industrywith at least3 years in Regulatory Affairsand product labeling.Proven understanding ofglobal labeling regulations(FDA EMA CIOMS) and regulatory documentation standards.Demonstrated ability to interpret clinical and technical data and translate findings into compliant labeling text.Strong skills inscientific writingdata interpretationanddocument management systems (DMS).Excellent communication and interpersonal skills with the ability to work in amatrixed cross functional environment.Proficiency inMicrosoft Wordwith working knowledge ofExcelandPowerPoint.Desirable:Advanced degree (MS PhD MD or PharmD) in a life sciences discipline.Experience leading projects or small teams in a global regulatory or labeling capacity.Previous participation inprocess improvementorcompliance initiatives.Experience withlabeling systemsand tools supporting compliance and document traceability.Key CompetenciesStrong scientific and analytical thinking.Excellent attention to detail and quality orientation.Ability to manage multiple projects and priorities effectively.Clear and professional communication with internal and external stakeholders.Proactive problem solving and decision making mindset.Collaborative customer focused and continuous improvement driven approach.