Regulatory Affairs Manager

Manager Regulatory Affairs – Global Labeling Product LeaderLocation: Poland (Remote)Type: Full Time | 12 Month Fixed Term Contract (FTC)Start Date: ASAPAbout the Company:Our client is a global healthcare leader specializing 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:The Manager Global Labeling Product Leader is responsible for the development maintenance and quality oversight of 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 the creation revision and maintenance of primary and derived labeling documents (for example CCDS USPI SmPC) ensuring alignment with regulatory requirements and company strategy.Collaborate cross functionally with Subject Matter Experts (SMEs) through Labeling Working Groups (LWG) and Labeling 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 of global labeling strategies including the development of target labeling for new and existing products.Partner with Global Regulatory Affairs (GRA) and Global 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 and Corrective and Preventive Action (CAPA) management related to labeling activities.Contribute to continuous improvement initiatives to 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 in Life Sciences Pharmacy or a related discipline.Minimum 4 years of experience in the pharmaceutical or healthcare industry with at least 3 years in Regulatory Affairs and product labeling.Proven understanding of global 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 in scientific writing data interpretation and document management systems (DMS).Excellent communication and interpersonal skills with the ability to work in a matrixed cross functional environment.Proficiency in Microsoft Word with working knowledge of Excel and PowerPoint.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 in process improvement or compliance initiatives.Experience with labeling systems and 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.