Regulatory Information Specialist

Title:

Regulatory Information Specialist

Company:

Ipsen Innovation (SAS)

 

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 company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

The Regulatory Information Specialist plays a crucial role in managing regulatory data, ensuring compliance with EMA requirements, and optimizing regulatory information systems. This position primarily focuses on managing regulatory structured data, administering EMA-related systems, and enhancing SharePoint functionalities within the Global Regulatory Affairs (GRA) framework.

WHAT - Main Responsibilities & Technical Competencies

 Regulatory Structured Data management

• Support IDMP readiness activities, with a focus on regulatory data, to ensure alignment with EMA standards.
• Perform data remediation to enrich the RIM database and ensure consistency with IDMP standards.
• Fulfill EMA data-related requests (e.g., QC of PMS data, manufacturer enrichment in PMS).
• Define and implement IDMP data flow processes in collaboration with Subject Matter Experts (SMEs).
• Ensure compliance and create value through effective management of non-transactional regulatory data.
• Support xEVMPD submissions in close collaboration with contributing functions (including data owners).
• Perform quality control on data imports from xEVMPD to PMS.
• Align regulatory data management processes with Veeva Vault standards.
• Contribute to the optimization of regulatory data tracking and reporting.

EMA Systems Administration

• Handle EMA account access requests (SPOR, PLM, IRIS, CTIS,OMS…).
• Maintain documentation related to EMA accounts and associated trainings.
• Coordinate Ipsen’s compliance with EMA database obligations
• Communicate to Regulatory Community relevant information and potential actions to be done.

Regulatory SharePoint Management

• Work with GRA teams to identify needs and improve SharePoint sites.
• Evaluate technical feasibility, implement updates, and add automation where helpful.
• Ensure SharePoint sites work well and are easy to use.
• Handle requests for new site creation, content migration, and archival of outdated information.
• Monitor SharePoint usage and performance, and proactively address any issues.
• Provide user support and training to improve adoption and correct use of SharePoint features.
• Organize content using clear site structures to make information easier to find.
• Manage user access, permissions, and groups to ensure data security.
• Perform additional tasks related to access management, permissions, and other related needs as required.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 3 years of experience in database management
• Experience managing IDMP or XEVMPD.
• Proven ability to lead cross-functional projects.
• Strong organizational, interpersonal, and negotiation skills.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft applications (Excel, SharePoint, Power Automate, Power Apps).
• Good understanding of Regulatory Information Systems.
• In-depth knowledge of RIM data models and EMA regulatory systems.

Knowledge & Experience (preferred):

• Experience in the pharmaceutical industry
• Experience in Regulatory Affairs
• Experience with Master Data Management.

Education / Certifications (essential):

• Advanced degree in Life Sciences (Life Science Engineering or equivalent)

Language(s) (essential):

• Professional proficiency in English.

Language(s) (preferred):

• Fluent in French

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.