Expert Regulatory System

Description du poste et des missions

The Regulatory System Manager will play a pivotal role in optimizing and managing regulatory systems, with a primary focus on Veeva Regulatory Information Management (RIM). The ideal candidate will have 3-5 years of experience in regulatory affairs systems within a corporate setting. This role requires close collaboration with the IT and business stakeholders to enhance the regulatory ecosystems.

Main Responsibilities:

Training Management:

• Acquire comprehensive knowledge of system configurations and processes.


• Update and manage the evolution of existing training materials.


• Develop advanced and specialized training programs in collaboration with service providers.

Tool Evolution Participation:

• Support the Regulatory Systems Owner in change management initiatives within the regulatory ecosystem.


• Diagnose system performance and recommend areas for improvement.


• Conduct interviews with key stakeholders to harmonize processes and propose quick wins.

Oversight of Service Providers:

• Collaborate closely with the Systems Owner to oversee day-to-day service provider activities.


• Address and resolve level 2 user inquiries.


• Conduct regular follow-up meetings to monitor service provider performance.

Data Integration Management:

• Contribute to the data integration in our regulatory systems

Profil souhaité

Education:

• Degree in life science discipline or a related field (e.g., pharmacy, life science engineering, software), or equivalent professional experience.

Experience:

Required:

• At least 3-5 years of professional experience, including a minimum of 2-year experience in Corporate Regulatory Affairs or IT.


• Proficiency in learning and training management.


• Hands-on experience with regulatory systems development, validation.

Preferred:

• Experience in regulatory systems and ecosystems.


• Proven track record in managing system improvement projects.


• Familiarity with regulatory impact assessments and change management processes.

Skills:

• Fluent in English and French (written and oral).


• Strong organizational, interpersonal, and negotiation skills.


• Excellent written and oral communication abilities.


• Ability to diagnose system issues and propose improvement strategies.


• Tactful and helpful attitude with strong stakeholder management skills.

Compétences requises

Regulatory Information Management (RIM) Expertise:

• In-depth knowledge and hands-on experience with RIM (Veeva Preferred), including system configuration, process optimization, and training delivery.

Systems Development & Validation:

• Strong understanding of regulatory systems development life cycle, including system validation, testing, and documentation.

Regulatory Ecosystems & Change Management:

• Experience in managing and supporting change within regulatory ecosystems, including impact assessments, stakeholder engagement, and process harmonization.

Training Management & Development:

• Ability to design, develop, and deliver comprehensive training programs for regulatory systems users, including the creation of specialized and advanced training materials.

System Diagnosis & Troubleshooting:

• Capability to diagnose system issues, propose effective solutions, and implement improvements to enhance system performance and user satisfaction.

Data Management & Reporting:

• Familiarity with regulatory data management practices, including data integrity, reporting, and compliance with regulatory standards.

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

Informations du recruteur

Lieu de la mission