Your JobParticipation 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 profilesManages 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 CCDSsEscalates deviation and compliance issues to the labelling governance bodies (e.g.
Safety monitoring committee, Global labelling boards) as necessaryExperience in labelling documentation and informative texts for innovator drugs on a global (headquarter) levelEnsuring that regulatory affairs, development consulting and scientific affairs programs and projects are delivered to high standardsPlanning and expediting the approval projects using the internally available or client-based software tools including databases and document management systemsProviding regulatory expertise to regulatory programs and projects as well as to clientsGeneral guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislationPresenting seminars and lectures on behalf of PharmaLex internally, for customers and for professional audiencesCreation, revision, editing and maintenance of regulatory documentationProfessional interaction with clients and Health AuthoritiesCoordination of project teams with internal / external staff and Regulatory Alliance Partners on a world-wide levelParticipation in strategic regulatory issues incl.
definition of suitable methods of resolutionTechnical support to business development with particular focus on Labeling activities and adjacent areas on EU level and preferably also on global level Your Profile You speak fluent business English or English is your mother tongue, preferably you also have skills in another EU languageYou have successfully completed preferably a degree in pharmacy, medicine or other life sciences or a bachelor's degree in science, engineering or mathematical domainYou have professional experience in regulatory affairs with a profound track record in labeling activities for innovator drugs on a global levelYou bring experience in handling of marketing authorizations and their lifecycle managementYou have sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH regionYou have an affinity for databases, labeling software tools and project management software and are used to closely monitor and adhere to timelinesYou are a team player, communicative, conscientious, accurate and responsibleConfident with MS Excel and MS Word as well as databases and document management systems We offer Diverse and challenging jobOpen and appreciative corporate cultureFlexible working hours based on trustPossibility to work reduced number of hours Possibility to work from home Continuous development opportunities through knowledge and experience as well as training
