We are seeking an experienced Global Regulatory Lead (Global & US Regulatory) to lead global regulatory strategy for an approved immunology product within the Deucravacitinib (DeUC) Program . The successful candidate will partner closely with the US Regulatory Lead (USRL) and cross-functional global teams to develop and execute regulatory strategies supporting lifecycle management, supplemental indications, and post-marketing activities.
This role requires strong expertise in global regulatory affairs, health authority interactions, regulatory risk assessment, and submission strategy, with preference for candidates experienced in psoriasis and psoriatic arthritis .
Key Responsibilities
- Lead the development and execution of global regulatory strategies for assigned products and indications.
- Partner with the US Regulatory Lead (USRL) to ensure alignment between global and US regulatory strategies.
- Drive regulatory planning and execution for supplemental submissions, lifecycle management activities, and post-marketing requirements (PMRs).




- Lead regulatory assessments and provide strategic advice to project teams regarding regulatory risks, opportunities, and submission pathways.
- Represent Integral Regulatory on cross-functional project teams and Global Regulatory Teams (GRTs).
- Plan, prepare, and lead Health Authority interactions, including written responses and regulatory meetings.
- Evaluate evolving global regulatory requirements and assess their impact on product development and commercialization.
- Collaborate with Clinical Development, Medical Affairs, Safety, CMC, Quality, Commercial, and regional regulatory teams to ensure successful execution of regulatory strategies.
- Support regulatory documentation, submission planning, and agency communications.
- Identify regulatory risks and develop mitigation strategies to support successful approvals and lifecycle management.
- Effectively communicate complex regulatory issues to senior leadership and key sta

📌 Global Regulatory Lead (España)
🏢 VBeyond
📍 España