Regulatory Affairs Consultant Labelling - German Speaker

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.We are seeking an experienced Regulatory Affairs Consultant specializing in global labelling operations to join our growing Regulatory Affairs team. This role offers the opportunity to shape labelling strategy across multiple markets and drive global alignment of product information for pharmaceutical portfolio of our clients.

The role can be fully home based or office based.

Key Responsibilities:Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenanceProvide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirementsExecute labeling operations globally with precision and efficiencyParticipate in a 'follow the sun' model to ensure timely execution of labelling activities across time zonesPrepare and review labelling documents for regulatory submissions and variationsMaintain labeling databases and tracking systemsSupport global labelling harmonization initiativesCollaborate with regional regulatory teams to ensure compliance with local requirementsMonitor regulatory intelligence related to labelling requirementsSkills and Experienced required for the role:University degree in a life science disciplineA few years of

experience in the biotech/pharmaceutical industryLabelling/regulatory experience with global responsibilitiesExperience with CCDS development and maintenanceStrong understanding of regulatory labelling requirements across multiple marketsDirect experience working with SwissmedicExcellent attention to detail and organizational skillsExperience leading teams in a matrix organization is expectedAbility to work effectively in a global, virtual team environmentFluent in German and English, written and spokenSummaryLocation: Switzerland-Remote; Germany-Berlin-Remote