Regulatory Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/799lm2

Location : Milan, Italy ( 1 day onsite per week) 24 Months Fixed Term Role Job Summary The Regulatory Project Manager is responsible for leading and coordinating regulatory activities across the product lifecycle, with a strong focus on managing submissions in the US and EU regions. This role ensures timely execution of regulatory strategies, financial oversight of projects, and effective collaboration with cross-functional teams and external partners to achieve compliance and business objectives. Key Responsibilities Regulatory Project Management * Plan, track, and manage regulatory submissions for US (FDA) and EU (EMA/Notified Bodies) markets. * Maintain detailed timelines and ensure adherence to submission milestones and regulatory deadlines. * Identify risks and proactively implement mitigation strategies to avoid delays or compliance issues. * Monitor project-related expenses, investments, and budgets. * Track financial performance and ensure alignment with approved budgets and forecasts. * Collaborate with finance teams to provide regular financial updates, variance analysis, and cost optimization opportunities. Stakeholder Coordination * Act as the primary liaison between internal functions (Regulatory Affairs, Clinical, Quality, R&D;, Finance) and external stakeholders (consultants, partners, regulatory bodies). * Facilitate effective communication to ensure alignment on project scope, timelines, and deliverables. * Organize and lead cross-functional meetings,



providing clear updates and action plans. Product Lifecycle Oversight * Ensure comprehensive oversight of regulatory activities throughout the entire product lifecycle—from development through post-market. * Support regulatory strategy development and execution in alignment with company goals. * Monitor post-approval commitments, variations, renewals, and compliance requirements. Documentation & Compliance * Ensure accurate and complete regulatory documentation is maintained. * Support preparation, review, and submission of regulatory dossiers. * Ensure compliance with applicable regulatory standards and internal procedures. Qualifications * Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field (Master's degree preferred). * 5+ years of experience in regulatory affairs, project management, or related roles within the pharmaceutical, biotechnology, or medical device industry. * Strong understanding of US and EU regulatory frameworks and submission processes. * Excellent project management and organizational skills. * Strong financial acumen with the ability to track and manage budgets. * Effective communication and stakeholder management abilities. * Detail-oriented with strong problem-solving skills. * Ability to manage multiple projects in a fast-paced environment. Nice to Have: * Prior experience with Monday.com Regulatory Project Manager Lombardy, Italy #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/799lm2