Regulatory Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78yt6q

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-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78yt6q