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Regulatory Information Management Expert - Job Opportunity at Ipsen Innovation (SAS)

Boulogne-Billancourt, France
Full-time
Senior
Posted: March 5, 2025
Hybrid
EUR 65,000 - 85,000 annually based on Paris market rates for senior regulatory specialists

Benefits

Hybrid work arrangement (60% office, 40% remote)
Pharmaceutical industry standard benefits package
Professional development opportunities in regulatory systems
Cross-functional collaboration environment

Key Responsibilities

Lead xEVMPD submissions and maintain regulatory compliance with EMA requirements
Drive IDMP readiness initiatives and data standardization
Manage regulatory SharePoint administration and system optimizations
Coordinate EMA systems access and database compliance
Oversee PSR/RMP planning and stakeholder communication

Requirements

Education

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

Experience

5 years of experience in regulatory database management, 3 years of experience managing XEVMPD, IDMP activities

Required Skills

Strong organizational skills Interpersonal and negotiation abilities Written and verbal communication excellence Microsoft applications proficiency (Excel, SharePoint, Power Automate, Power Apps) Regulatory Information Systems expertise RIM data models knowledge EMA regulatory systems proficiency
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory complexity in pharmaceutical data management is driving demand for specialized RIM expertise Digital transformation of regulatory processes is creating new opportunities for automation and efficiency gains Growing focus on data standardization and interoperability across global markets

Role Significance

Typically part of a 5-8 person regulatory operations team, collaborating with broader regulatory affairs department of 20-30 professionals
Senior specialist position with significant strategic impact on regulatory compliance and data management efficiency

Key Projects

IDMP implementation and compliance programs Regulatory information system modernization Cross-functional data standardization initiatives Process automation and efficiency improvements

Success Factors

Deep understanding of regulatory data models and EMA requirements Strong project management capabilities in complex regulatory environments Excellent stakeholder management across multiple functions Balance of technical expertise and business process understanding

Market Demand

High demand due to evolving EMA requirements and industry-wide digital transformation initiatives

Important Skills

Critical Skills

Regulatory database management expertise due to increasing complexity of submissions Project management capabilities for cross-functional initiatives Technical understanding of data models and regulatory systems

Beneficial Skills

Change management experience Process automation knowledge Data analytics capabilities Quality management system expertise

Unique Aspects

Combination of technical regulatory expertise with information systems management
Strategic role in digital transformation of regulatory processes
Direct impact on company's regulatory compliance and efficiency

Career Growth

2-4 years in role before advancement, dependent on project success and organizational growth

Potential Next Roles

Head of Regulatory Operations Regulatory Information Systems Director Global Regulatory Affairs Strategy Lead

Company Overview

Ipsen Innovation (SAS)

Ipsen is a global biopharmaceutical company focused on specialty care and innovative medicines

Mid-sized pharmaceutical player with strong European presence and growing global footprint
Strategic position in French pharmaceutical sector with significant European operations
Professional environment with emphasis on compliance, innovation, and cross-functional collaboration
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