Regulatory Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ak8um

p Title : Regulatory Project Manager p Location : Milan , Italy ( 1 day onsite per week) /pp24 Months Fixed Term Role /pp Job Summary /pp 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. /pp Key Responsibilities /pp Regulatory Project Management /pulli Plan, track, and manage regulatory submissions for US (FDA) and EU (EMA/Notified Bodies) markets. /lili Maintain detailed timelines and ensure adherence to submission milestones and regulatory deadlines. /lili Identify risks and proactively implement mitigation strategies to avoid delays or compliance issues. /li /ulp Financial Oversight /pulli Monitor project-related expenses, investments, and budgets. /lili Track financial performance and ensure alignment with approved budgets and forecasts. /lili Collaborate with finance teams to provide regular financial updates, variance analysis, and cost optimization opportunities. /li /ulp Stakeholder Coordination /pulli Act as the primary liaison between internal functions (Regulatory Affairs, Clinical, Quality, RD, Finance) and external stakeholders (consultants, partners, regulatory bodies). /lili Facilitate effective communication to ensure alignment on project scope, timelines, and deliverables.



/lili Organize and lead cross-functional meetings, providing clear updates and action plans. /li /ulp Product Lifecycle Oversight /pulli Ensure comprehensive oversight of regulatory activities throughout the entire product lifecycle—from development through post-market. /lili Support regulatory strategy development and execution in alignment with company goals. /lili Monitor post-approval commitments, variations, renewals, and compliance requirements. /li /ulp Documentation Compliance /pulli Ensure accurate and complete regulatory documentation is maintained. /lili Support preparation, review, and submission of regulatory dossiers. /lili Ensure compliance with applicable regulatory standards and internal procedures. /li /ulp Qualifications /pulli Bachelor'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. /lili Strong understanding of US and EU regulatory frameworks and submission processes. /li /ulp Skills Competencies /pulli Excellent project management and organizational skills. /lili Strong financial acumen with the ability to track and manage budgets. /lili Effective communication and stakeholder management abilities. /lili Detail-oriented with strong problem-solving skills. /lili Ability to manage multiple projects in a fast-paced environment. /li /ulp Nice to Have: /pulli Prior experience with Monday.com /li /ul /p

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ak8um