Critères de l'offre
Métiers :
- Legal Associate
Secteur :
- Recrutement et placement
Diplômes :
- Bac+5, Master - Magistère, MIAGE
Compétences :
- Anglais
Lieux :
- Paris (75)
Conditions :
- Alternance / Apprentissage
- Temps Plein
Description du poste
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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