Le poste détaillé

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