Apprentice - GRA Regulatory IntelligenceIPSEN

Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.

Job Title: Master 2 Apprentice - GRA Regulatory Intelligence

Division / Function: [Global Regulatory Affairs (GRA), GRA Regulatory Intelligence & Policy]

Manager's Job Title: [Director, Global Regulatory Intelligence & Policy]

WHAT - Summary & Purpose of the Position

The apprentice will join the Ipsen's Global Regulatory Affairs (GRA) Regulatory Intelligence & Policy team. His/her role aims to develop foundational skills in regulatory intelligence while contributing to the team's weekly, monthly, and ad‑hoc deliverables.

Under supervision, the apprentice will:

• Monitor, collect, and summarize regulatory updates from health authorities.
• Draft and support the weekly GRA Regulatory Intelligence newsletter (RADAR).
• Assist with ad‑hoc regulatory intelligence requests from GRA teams.
• Contribute to competitive regulatory intelligence activities.
• Help maintain and update internal regulatory intelligence tools and processes.

This role is designed as a learning opportunity for a motivated Master's student seeking to develop regulatory affairs expertise

WHAT - Main Responsibilities & Technical Competencies

Main responsibilities:

Regulatory Intelligence Operations - Weekly RADAR

• Identify and summarize basic regulatory updates from predefined sources.
• Support the drafting and preparation of the weekly RADAR newsletter.
• Help consolidate information from global regulatory agencies.

Regulatory Surveillance - Ad Hoc Activities

• Help prepare Regulatory Intelligence Flash communications for urgent topics.
• Conduct initial research for punctual regulatory questions from GRA teams.
• Support the collection of Ipsen comments during regulatory consultations.

Competitive Regulatory Intelligence

• Identify key competitor products and basic regulatory milestones.
• Monitor publicly available information on competitor regulatory activity.
• Organize collected information under supervision.

Support to GxP Regulatory Intelligence Process

• Assist in implementing the new GxP Regulatory Intelligence Process.
• Help coordinate with SMEs on regulatory updates impacting SOPs.
• Provide administrative support for process documentation.

Technical competencies:

• Interest in regulatory affairs and willingness to learn regulatory frameworks.
• Ability to search, collect, and structure information from predefined sources.
• Good summarizing and writing skills (training provided).
• Strong attention to detail and reliability.
• Ability to learn how to use regulatory databases.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Education: Currently enrolled in a Master 2 in Life Sciences, Pharmacy, Public Health, or related field.

• Experience: First experience (internship or academic project) in the pharmaceutical sector is a plus but not required.

• Understanding: willingness to acquire knowledge of research, development, and regulatory concepts.

• Languages:
  • French
  • English is mandatory