Regulatory Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ce3yy

ppLocation : bMilan , Italy ( 1 day onsite per week) /b /p h3Job Summary /h3 pThe 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. /p h3Key Responsibilities /h3 h3Regulatory Project Management /h3 ul liPlan, track, and manage regulatory submissions for US (FDA) and EU (EMA/Notified Bodies) markets. /li liMaintain detailed timelines and ensure adherence to submission milestones and regulatory deadlines. /li liIdentify risks and proactively implement mitigation strategies to avoid delays or compliance issues. /li liMonitor project‑related expenses, investments, and budgets. /li liTrack financial performance and ensure alignment with approved budgets and forecasts. /li liCollaborate with finance teams to provide regular financial updates, variance analysis, and cost optimization opportunities. /li /ul h3Stakeholder Coordination /h3 ul liAct as the primary liaison between internal functions (Regulatory Affairs, Clinical, Quality, RD, Finance) and external stakeholders (consultants, partners, regulatory bodies). /li liFacilitate effective communication to ensure alignment on project scope, timelines, and deliverables.



/li liOrganize and lead cross‑functional meetings, providing clear updates and action plans. /li /ul h3Product Lifecycle Oversight /h3 ul liEnsure comprehensive oversight of regulatory activities throughout the entire product lifecycle—from development through post‑market. /li liSupport regulatory strategy development and execution in alignment with company goals. /li liMonitor post‑approval commitments, variations, renewals, and compliance requirements. /li /ul h3Documentation Compliance /h3 ul liEnsure accurate and complete regulatory documentation is maintained. /li liSupport preparation, review, and submission of regulatory dossiers. /li liEnsure compliance with applicable regulatory standards and internal procedures. /li /ul h3Qualifications /h3 ul liBachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field (Master’s degree preferred). /li li5+ years of experience in regulatory affairs, project management, or related roles within the pharmaceutical, biotechnology, or medical device industry. /li liStrong understanding of US and EU regulatory frameworks and submission processes. /li liExcellent project management and organizational skills. /li liStrong financial acumen with the ability to track and manage budgets. /li liEffective communication and stakeholder management abilities. /li liDetail‑oriented with strong problem‑solving skills. /li liAbility to manage multiple projects in a fast‑paced environment. /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ce3yy