Regulatory Project Manager
Pubblicato il 15-08-2026 - Freyr Solutions in Italia
Milan , Italy ( 1 day onsite per week) Job Summary
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.
Regulatory Project Management
Identify risks and proactively implement mitigation strategies to avoid delays or compliance issues.
Monitor project‐related expenses, investments, and budgets.
Collaborate with finance teams to provide regular financial updates, variance analysis, and cost optimization opportunities.
Act as the primary liaison between internal functions (Regulatory Affairs, Clinical, Quality, R&D;, Finance) and external stakeholders (consultants, partners, regulatory bodies).
Facilitate effective communication to ensure alignment on project scope,
timelines, and deliverables.
Product Lifecycle Oversight
Ensure comprehensive oversight of regulatory activities throughout the entire product lifecycle—from development through post‐market.
Monitor post‐approval commitments, variations, renewals, and compliance requirements.
Documentation & Compliance
Ensure compliance with applicable regulatory standards and internal procedures.
Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field (Master's degree preferred).
5+ years of experience in regulatory affairs, project management, or related roles within the pharmaceutical, biotechnology, or medical device industry.
Excellent project management and organizational skills.
Effective communication and stakeholder management abilities.
Ability to manage multiple projects in a fast‐paced environment.