Senior Regulatory- Labelling

Description

Summary: Join a dynamic team as a Regulatory Affairs Labelling Expert, contributing to innovative projects and making a global impact in healthcare. Highlights: 1. Make a global impact in healthcare through regulatory affairs and labelling. 2. Contribute to innovative projects that improve lives worldwide. 3. Collaborate with a diverse, global team of professionals. **What you will be doing** ========================== **Join Our Team as a Regulatory Affairs Labelling Expert!** Are you ready to make a global impact in healthcare? We're seeking passionate and experienced professionals to join our dynamic team in the field of regulatory affairs and labelling. If you're looking for a challenging and rewarding career, this is your chance to contribute to innovative projects that improve lives worldwide. Key Responsibilities * Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and also for non\-EU markets, preferably including development of target product/labelling profiles * Manages creation and maintenance of CCDS/CCSI/RSI, as applicable, in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e.g. from medical, safety department) * Ensures communication to internal / external stakeholders regarding new and updated CCDSs and Product Information * Escalates deviation and compliance issues to the labelling governance bodies (e.g. Safety monitoring committee, Global labelling boards) as necessary * Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level * Planning and expediting the approval projects using the internally available or client\-based software tools including databases and document management systems * Providing regulatory expertise to regulatory programs and projects as well as to clients * General guidance (consultancy) of Cencora staff and customers regarding Regulatory Submissions \& Labelling activities including also updates on new trends and/or changes in legislation * Creation, revision, editing and maintenance of regulatory documentation * Professional interaction with clients and Health Authorities * Coordination of project teams with internal / external staff and Regulatory Partners on a world\-wide level * Participation in strategic regulatory issues incl. definition of suitable methods of resolution What You Bring * Language Proficiency: Fluent business English (or native English), with additional EU language skills as a plus. * Educational Background: A degree in pharmacy, medicine, life sciences, or a bachelor’s degree in science * Regulatory Affairs Expertise: Proven experience in regulatory affairs with a strong track record in labelling activities for innovator drugs on a global level. * Lifecycle Management: Experience in handling marketing authorizations and their lifecycle management. * Regulatory Knowledge: Sound understanding of pharmaceutical and regulatory requirements in the EU and ideally in one ICH region. * Technical Skills: Affinity for databases, labelling software tools, and project management software, with the ability to monitor and adhere to timelines. * Personal Attributes: Team player with excellent communication skills, conscientious, accurate, and responsible. * Software Proficiency: Confident in using MS Excel, MS Word, databases, and document management systems . * Drive Effective Communication: Ensure timely updates and communication regarding new and revised CCDSs and Product Information to internal and external stakeholders. * Ensure Compliance: Escalate deviations and compliance issues to labelling governance bodies such as safety monitoring committees and global labelling boards. * Regulatory Expertise: Provide expert regulatory guidance to programs, projects, and clients, while staying ahead of new trends and legislative changes. * Collaborate Globally: Coordinate project teams with internal/external staff and regulatory partners worldwide, ensuring seamless execution and adherence to timelines. * Client and Authority Interaction: Build professional relationships with clients and health authorities, ensuring effective communication and collaboration. **What your background should look like** ========================================= Why Join Us? * Be part of a forward\-thinking organization that values innovation and excellence. * Work on impactful projects that shape the future of healthcare. * Collaborate with a diverse, global team of professionals. * Enjoy opportunities for professional growth and development. * Make a difference in patients' lives through your expertise. Please note this role is to act as an individual contributor, not to manage a team. This role is a remote position. If you're ready to take your career to the next level and thrive in a challenging yet rewarding environment, we want to hear from you! Apply now and become a vital part of our mission to improve healthcare worldwide. **Schedule** ============ Full time