Regulatory Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bezj4

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/7bezj4