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Senior Regulatory- Labelling

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Cencora

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Job Description:

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.

Job Responsibility:

  • 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
  • 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

Requirements:

  • 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

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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