Apprentice GRA Regulatory Intelligence

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:Master 2 Apprentice - GRA Regulatory Intelligence

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

Managers Job Title: Director Global Regulatory Intelligence & Policy

WHAT - Summary & Purpose of the Position

The apprentice will join the Ipsens Global Regulatory Affairs (GRA) Regulatory Intelligence & Policy team. His/her role aims to develop foundational skills in regulatory intelligence while contributing to the teams weekly monthly and adhoc 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 adhoc 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 Masters 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