Regulatory Affairs Project Manager

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Excelya

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.

📋 Description

• Lead the planning, coordination, and execution of global regulatory submission strategies across FDA, EU, China, and Japan markets • Manage dossier preparation, compilation, and submission activities while ensuring regulatory compliance and timelines • Coordinate external service providers and publishing vendors for dossier delivery and submissions • Identify submission risks, address resource constraints, and support problem-solving to maintain project timelines • Drive regulatory submission activities throughout the product lifecycle, from First-in-Human studies through license withdrawal • Partner with Global and Regional Regulatory Leads and cross-functional teams on global regulatory roadmaps • Build and maintain project management tools, submission schedules, dashboards, and milestone tracking • Oversee preparation of reference dossiers (Modules 2-5) aligned with global and local requirements • Monitor submission progress, manage dossier updates, coordinate responses to health authority questions, and ensure regulatory database compliance • Collaborate with Medical Writing, Clinical Development, R&D Operations, Technical Management, and external industry partners

🎯 Requirements

• Proven experience in global regulatory submissions and regulatory operations • Strong knowledge of eCTD dossier preparation, publishing, and submission processes • Experience with FDA, EMA, China, and Japan regulatory requirements • Excellent project management and stakeholder coordination skills • Ability to manage multiple priorities and meet challenging deadlines • Strong risk assessment and problem-solving capabilities • Experience working in cross-functional and international environments • Proactive, organized, and detail-oriented mindset • Excellent communication and collaboration skills • Fluent in English (written and spoken)

🏖️ Benefits

• Diverse projects through a one-stop provider service model offering full-service, functional service provider, and consulting • Opportunity to work alongside preeminent experts • Environment that values natural talents, pushes boundaries with audacity, and nurtures professional potential • Best employee experience focus • Opportunity to contribute to improving scientific, operational, and human knowledge to enhance the patient’s journey