ppWe are seeking an experienced bGlobal Regulatory Lead (Global US Regulatory) /bto lead global regulatory strategy for an approved immunology product within the bDeucravacitinib (DeUC) /b bProgram /b. 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. /ppThis role requires strong expertise in global regulatory affairs, health authority interactions, regulatory risk assessment, and submission strategy, with preference for candidates experienced in bpsoriasis and psoriatic arthritis /b. /ppbKey Responsibilities /b /pulliLead the development and execution of global regulatory strategies for assigned products and indications. /liliPartner with the US Regulatory Lead (USRL) to ensure alignment between global and US regulatory strategies. /liliDrive regulatory planning and execution for supplemental submissions, lifecycle management activities, and post-marketing requirements (PMRs). /liliLead regulatory assessments and provide strategic advice to project teams regarding regulatory risks, opportunities, and submission pathways. /liliRepresent Global Regulatory on cross-functional project teams and Integral Regulatory Teams (GRTs). /liliPlan, prepare, and lead Health Authority interactions, including written responses and regulatory meetings. /liliEvaluate evolving global regulatory requirements and assess their impact on product development and commercialization. /liliCollaborate with Clinical Development, Medical Affairs, Safety, CMC, Quality, Commercial,



and regional regulatory teams to ensure successful execution of regulatory strategies. /liliSupport regulatory documentation, submission planning, and agency communications. /liliIdentify regulatory risks and develop mitigation strategies to support successful approvals and lifecycle management. /liliEffectively communicate complex regulatory issues to senior leadership and key stakeholders. /li /ulpbRequired Qualifications /b /pulliBachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline (Advanced degree preferred). /lili8–10+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry. /liliDemonstrated experience as a Global Regulatory Lead (GRL) or in a similar strategic global regulatory role. /liliStrong experience partnering with or supporting US Regulatory Lead (USRL) activities. /liliExtensive knowledge of US and global regulatory requirements and submission processes. /li /ulpProven experience leading: /pulliGlobal regulatory strategy /liliSupplemental submissions (sNDA/sBLA) /liliHealth Authority interactions /liliPost-Marketing Requirements (PMRs) /liliStrong regulatory risk assessment and strategic decision-making capabilities. /liliExperience working within cross-functional global development teams. /li /ulpbPreferred Qualifications /b /pulliExperience supporting approved products with multiple supplemental indications. /li /ulpTherapeutic expertise in: /pulliPsoriatic Arthritis /liliExperience with Deucravacitinib (DeUC) or similar immunology products is highly desirable. /liliExperience leading global regulatory teams across multiple regions. /li /ul /p #J-18808-Ljbffr

📌 Global Regulatory Lead (España)
🏢 VBeyond
📍 España