Senior Manager, Data Transparency & Regulatory Disclosure

Ipsen

Paris

Hybrid

GBP 80,000 - 110,000

Full time

7 days ago
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Job summary

Ipsen seeks a Senior Manager, Data Transparency and Regulatory Disclosure to lead global clinical data transparency initiatives and regulatory disclosure programs. You will collaborate with Regulatory Affairs Excellence and external vendors to ensure compliant publication across CTIS, EMA policies, and related platforms.

The role requires strategic leadership across therapeutic areas, oversight of FOI requests, and the production of clear lay summaries while driving process improvements and

Responsibilities

  • Lead or support planning and execution of clinical data disclosure activities across public registries and regulatory platforms (e.g., CTIS, EMA Policy 0070, Health Canada PRCI).
  • Act as primary DTRD contact for assigned therapeutic areas (e.g., neuroscience, rare diseases, oncology).
  • Govern and support access to information requests under FOI laws (e.g., US FOIA, EMA Policy 0043).
  • Manage relationships with external vendors supporting transparency, lay language summaries, and redaction services.
  • Communicate complex strategic concepts clearly to diverse audiences.
  • Lead cross-functional collaboration to keep transparency deliverables on track and within scope.
  • Drive process improvements and implement new technologies for efficiency and compliance.
  • Contribute to regulatory intelligence, external engagement, SOPs and training materials.
  • Demonstrate thought leadership by presenting industry trends and benchmarking insights.

Job description

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 endeavour 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.

Senior Manager, Data Transparency and Regulatory Disclosure

Location: Paris, France & London, United Kingdom
Department: Global Regulatory Affairs Excellence, R&D

Summary & Purpose of the Position

Reporting to the Head of the Regulatory Clinical Trial Excellence & Data Transparency within GRA Excellence, the Senior Manager, Data Transparency and Regulatory Disclosure (DTRD) plays a strategic and operational leadership role in advancing Ipsen's global clinical data transparency and disclosure agenda. This position serves as a subject matter expert, supporting cross-functional teams and strategic partners to ensure compliance with global and local transparency regulations, while fostering a culture of excellence, innovation, and collaboration.

Key Responsibilities
  • Lead or support the planning and execution of clinical data disclosure activities across public registries and regulatory platforms (e.g., CTIS, EMA Policy 0070, Health Canada PRCI).
  • Act as the primary DTRD contact for assigned therapeutic areas (e.g., neuroscience, rare diseases, oncology), managing end-to-end disclosure processes and advising on regulatory requirements.
  • Govern and support access to information requests under Freedom of Information (FOI) laws (e.g., US FOIA, EMA Policy 0043), ensuring timely and compliant responses.
  • Manage relationships with external vendors supporting transparency, lay language summaries, and redaction services, ensuring quality, timelines, and budget adherence.
  • Communicate complex strategic concepts clearly and effectively, tailoring messages to diverse internal and external audiences.
  • Lead cross-functional collaboration to ensure transparency deliverables remain on track and within scope.
  • Drive process improvements and implement new technologies to enhance operational efficiency and compliance.
  • Contribute to regulatory intelligence, external engagement, SOPs and training material development to align with evolving global standards.
  • Demonstrate thought leadership by presenting industry trends, benchmarking insights, and best
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