Apprenticeship Global Labelling Specialist

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Job Title:

APPRENTICESHIP GLOBAL LABELLING SPECIALIST

Division / Function:

Global Regulatory Affairs Regulatory Operations

Managers Job Title:

Global Head Labelling Senior Director

WHAT - Summary & Purpose of the Position

As a Global Labelling apprentice you will support the management and maintenance of Company Core Data Sheets (CCDS) and European Product Information (EU PI) in a highly dynamic regulatory environment.

Your role will particularly focus on:

• supporting the expanded scope of EU PI management across products
• contributing to the implementation of the new EMA QRD template requiring full updates of EU PI for centrally authorised products.

You will work in close collaboration with Global Labelling Global Regulatory Affairs (GRA TA) and cross-functional teams to ensure high-quality compliant and consistent labelling aligned with regulatory requirements and company standards.

Additionally as part of the continuous improvement of the labelling function you will also be involved in the process updates working closely with the process owner GRA Compliance and Quality.

WHAT - Main Responsibilities & Technical Competencies

Main tasks

• Collaborate with the Global Labelling team to understand their processes workflows and requirements.
• Support the preparation update and review of labelling updates (CCDS EU PI or escalated PI)
• Contribute to the documentation and traceability of labelling updates
• Contribute to the implementation of the new EMA QRD template including:

• impact assessment on existing EU PI
• support to EU PI updates across products
• identification of gaps vs QRD requirements

• Assist in ensuring that EU PI are:

• consistent with source data and regulatory dossier
• aligned with CCDS
• compliant with EU PI guidelines and QRD template

• Perform checks of EU PI against the CCDS to ensure central alignment and proactively identify any differences including support to their documentation (gap analysis or non-conformance) and escalation when relevant
• Participate in cross-functional labelling activities (PI LAT) including:

• coordination with GRA TA Medical Safety and other stakeholders
• contribution to review cycles and consolidation of comments
• support the preparation of materials for Executive Labelling Committee (ELC) discussions and presentations including consolidation of key differences and supporting rationale

• Support the harmonisation and standardisation of labelling practices across products
• Participate in process improvement initiatives related to CCDS or EU PI management working closely with the process owner GRA Compliance and Quality teams
• Contribute to documentation and traceability of labelling updates

GRA Trainee Academy active team member

• Attend/present at GRA/GL knowledge sharing meetings.
• Attend Ipsen internal events (presentations external speakers forums webinars celebrations )
• Ensures adequate reporting of his/her activities and participates to various meetings depending on project assignments.
• Be an active member of the GRA Trainee Academy (specific program designed to provide a framework for the GRA interns and apprentices only): attending proposed trainings prepare webcast share experience build network site visits (if possible) get exposure to senior management. Provide feedback and participate in Trainee Academy further development and visibility.

HOW - Behavioural Competencies Required

• Strong analytical and organizational skills
• High level of attention to detail and quality
• Good communication and interpersonal skills
• Ability to work in a cross-functional international environment
• Proactivity and willingness to learn in a complex regulatory setting

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Knowledge in Regulatory affairs
• Strong interest in Product Information / Labelling activities
• Good proficiency in Microsoft Office (Excel PowerPoint Word)

Education / Certifications (essential):

• Ongoing Masters degree in Life Sciences Pharmacy or Regulatory Affairs

Language(s) (essential):

• Professional English written and oral

Language(s) (preferred):

• French language fluent