Senior Manager, Data Transparency & Regulatory Disclosure at Ipsen in London

Job description

Title: Senior Manager, Data Transparency & Regulatory Disclosure Company: Ipsen Biopharm Ltd 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 endeavor 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 . Job Description: Senior Manager, Data Transparency and Regulatory Disclosure Global Regulatory Affairs Excellence, R&D Director, Head of Regulatory Clinical Trial Excellence & Data Transparency Paris, France & London, United Kingdom WHAT - 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 practices to internal stakeholders and at external events. • Proactively identify areas for improvement and develop strategic solutions to mitigate risks and maintain business continuity. WHAT - Main Responsibilities & Technical Competencies 1. Management of Therapeutic Area (TA) Disclosure Activities - Accountable for assessing the applicability of clinical studies and marketing applications for disclosure under US, EU, and other applicable regulations and Ipsen policy, and for planning and managing disclosure activities accordingly. - Act as the DTRD TA lead for assigned therapeutic areas (e.g., neuroscience, rare diseases, oncology), offering expert guidance on disclosure requirements and best practices, while balancing compliance and transparency obligations with a global strategic perspe