Regulatory Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/781dra

ppLocation : Milan , Italy ( 1 day onsite per week) /pp24 Months Fixed Term Role /ppJob Summary /ppThe 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. /ppKey Responsibilities /ppRegulatory Project Management /pulliPlan, track, and manage regulatory submissions for US (FDA) and EU (EMA/Notified Bodies) markets. /liliMaintain detailed timelines and ensure adherence to submission milestones and regulatory deadlines. /liliIdentify risks and proactively implement mitigation strategies to avoid delays or compliance issues. /liliMonitor project-related expenses, investments, and budgets. /liliTrack financial performance and ensure alignment with approved budgets and forecasts. /liliCollaborate with finance teams to provide regular financial updates, variance analysis, and cost optimization opportunities. /li /ulpStakeholder Coordination /pulliAct as the primary liaison between internal functions (Regulatory Affairs, Clinical, Quality, RD, Finance) and external stakeholders (consultants, partners, regulatory bodies). /liliFacilitate effective communication to ensure alignment on project scope, timelines, and deliverables. /liliOrganize and lead cross-functional meetings,



providing clear updates and action plans. /li /ulpProduct Lifecycle Oversight /pulliEnsure comprehensive oversight of regulatory activities throughout the entire product lifecycle—from development through post-market. /liliSupport regulatory strategy development and execution in alignment with company goals. /liliMonitor post-approval commitments, variations, renewals, and compliance requirements. /li /ulpDocumentation Compliance /pulliEnsure accurate and complete regulatory documentation is maintained. /liliSupport preparation, review, and submission of regulatory dossiers. /liliEnsure compliance with applicable regulatory standards and internal procedures. /li /ulpQualifications /pulliBachelor's degree in Life Sciences, Pharmacy, Engineering, or related field (Master's degree preferred). /lili5+ years of experience in regulatory affairs, project management, or related roles within the pharmaceutical, biotechnology, or medical device industry. /liliStrong understanding of US and EU regulatory frameworks and submission processes. /liliExcellent project management and organizational skills. /liliStrong financial acumen with the ability to track and manage budgets. /liliEffective communication and stakeholder management abilities. /liliDetail-oriented with strong problem-solving skills. /liliAbility to manage multiple projects in a fast-paced environment. /li /ulpNice to Have: /pulliPrior experience with Monday.com /li /ulpRegulatory Project Manager Lombardy, Italy /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/781dra