Ipsen

Manager, Global Regulatory Affairs

Ipsen

full-time

Posted on:

Location Type: Office

Location: Paris • France

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About the role

  • Accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide.
  • Provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects.
  • Act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the assigned product/project.
  • Ensure the development and flawless execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) for assigned region or worldwide.
  • Responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities or trade associations, particularly those that would benefit from a broad perspective on Ipsen regulatory policy.
  • Lead operational excellence initiatives within GRA

Requirements

  • Proven experience of drug development/registration and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
  • Track record of building excellent relationships with FDA and/or EU and Asia Pacific (mainly China and Japan) regulatory environment would be a plus.
  • Significant experience in the pharmaceutical industry approximately 4-7 years’ experience
  • Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
  • English
Benefits
  • workplace that champions human-centric leadership
  • culture of collaboration
  • excellence and impact
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
drug developmentregulatory strategyproduct registrationproject managementregulatory expertiseproduct maintenanceoperational excellencetherapeutic area knowledgeregulatory compliancescientific discipline
Soft Skills
relationship buildingcommunicationleadershipstrategic thinkingcollaborationproblem-solvinginfluencingorganizational skillsadaptabilityinitiative
Certifications
advanced degree