Regulatory Affairs, Manager
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• Act as Regulatory Team Leader on complex projects and guide regulatory deliverables
• Produce regulatory and technical documents with limited review
• Build relationships with customers and discuss regulatory issues directly
• Manage project budgets and revenue recognition, including out-of-scope activities
• Provide guidance to junior colleagues and support their development
• Present to clients at bid defense meetings on regulatory deliverables
• Draft or revise regulatory SOPs and review cross-functional SOPs
• Participate in Regulatory or IQVIA initiatives and global/regional programs
• Support regulatory strategies and timelines for MATs and publishing projects
• Liaise with Regulatory Agencies as needed
• Ensure adherence to SOPs and contribute to process improvements
• Adapt to a rapidly changing environment and collaborate with cross-functional teams Responsabilidades
• Bachelor in Lifescience or related discipline (minimum); Master in Lifescience is a plus
• At least 8 years of relevant regulatory experience
• Strong understanding of Ru0026D processes (CMC, preclinical, clinical) and regulatory guidelines
• Expert in planning and delivering work on time with quality standards
• Knowledge of regional regulatory procedures and marketing authorization transfers
• Experience with regulatory intelligence and cross-functional dependencies
• Ability to determine MATs, publishing strategies, and submission timelines
• Project leadership experience and ability to manage multiple projects
• Strong communication and client-facing skills
• Proficiency in Microsoft Office and publishing tools
• Ability to work under supervision on discrete tasks and propose system/process improvements
• Experience with pharmacovigilance aspects related to MA transfers
• Regulatory strategy development and documentation requirements Requisitos principales
• Hybrid work model
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