Apprentice - GRA Regulatory IntelligenceTALENTS HANDICAP

Paris 15 (75)Alternance / Apprentissage
Il y a 3 joursSoyez parmi les premiers à postuler

Description du poste

En tant qu'organisateur de forums de recrutement, Talents Handicap accompagne de très nombreuses entreprises & organisations en France dans leurs recrutements de collaborateurs en situation de handicap. Participant actuellement à l'un de nos forums.
L'entreprise IPSEN Pharma recherche actuellement des profils :

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

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