Manager Labelling and Regulatory Submissions

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Manager Labelling and Regulatory Submissions, Rome

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Client:

PharmaLex

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

9aa481b1bc33

Job Views:

10

Posted:

29.04.2025

Expiry Date:

13.06.2025

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Job Description:

Your Job

• 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
• 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
• Ensuring that regulatory affairs, development consulting and scientific affairs programs and projects are delivered to high standards
• 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 PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislation
• Presenting seminars and lectures on behalf of PharmaLex internally, for customers and for professional audiences
• 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 Alliance Partners on a world-wide level
• Participation in strategic regulatory issues incl. definition of suitable methods of resolution
• Technical 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 language
• You have successfully completed preferably a degree in pharmacy, medicine or other life sciences or a bachelor’s degree in science, engineering or mathematical domain
• You have professional experience in regulatory affairs with a profound track record in labeling activities for innovator drugs on a global level
• You bring experience in handling of marketing authorizations and their lifecycle management
• You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region
• You have an affinity for databases, labeling software tools and project management software and are used to closely monitor and adhere to timelines
• You are a team player, communicative, conscientious, accurate and responsible
• Confident with MS Excel and MS Word as well as databases and document management systems

We offer

• Diverse and challenging job
• Open and appreciative corporate culture
• Flexible working hours based on trust
• Possibility to work reduced number of hours
• Possibility to work from home
• Continuous development opportunities through knowledge and experience as well as training

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