Manager, Regulatory Affairs coordinating global regulatory submissions for therapeutic development. Collaborating cross - functionally to meet regulatory agency requirements and ensure compliance.
About the role
- Regulatory Systems Leader role at Pierre Fabre driving evolution and performance of regulatory platforms. Overseeing strategy implementation and ensuring user support.
Responsibilities
- Drive evolution, reliability, and performance of regulatory platforms
- Define strategy for regulatory systems
- Conduct active monitoring of regulatory developments
- Oversee implementation of defined strategy
- Provide technical expertise in complex operational environments
- Ensure user support and strengthen user adoption
Requirements
- Master’s degree (Bac +5) preferred
- At least 5 years of experience in Regulatory Affairs
- At least 5 years of experience in administering regulatory systems (RIM, Promomats, QMS, eCTD tools or similar)
- At least 7 years of experience in either Regulatory Affairs or database/system administration
- Experience in direct or indirect management including project management required
- Strong sense of ownership
- Comfort navigating complex environments
- Genuine interest in user experience and data integrity
- Fluent in English
Benefits
- Professional development opportunities
- Excellent communication skills
- Positive, team-oriented attitude
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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