Regulatory Project Manager

Location: Medolago

Title :
Regulatory Project Manager

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Location :
Milan , Italy ( 1 day onsite per week)
24 Months Fixed Term Role

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.

Key Responsibilities
Regulatory Project Management
Plan, track, and manage regulatory submissions for US (FDA) and EU (EMA/Notified Bodies) markets.
Maintain detailed timelines and ensure adherence to submission milestones and regulatory deadlines.
Identify risks and proactively implement mitigation strategies to avoid delays or compliance issues.
Financial Oversight
Monitor project-related expenses, investments, and budgets.
Track financial performance and ensure alignment with approved budgets and forecasts.
Collaborate with finance teams to provide regular financial updates, variance analysis, and cost optimization opportunities.
Stakeholder Coordination
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.
Organize and lead cross-functional meetings, providing clear updates and action plans.
Product Lifecycle Oversight
Ensure comprehensive oversight of regulatory activities throughout the entire product lifecycle—from development through post-market.
Support regulatory strategy development and execution in alignment with company goals.
Monitor post-approval commitments, variations, renewals, and compliance requirements.
Documentation & Compliance
Ensure accurate and complete regulatory documentation is maintained.
Support preparation, review, and submission of regulatory dossiers.
Ensure compliance with applicable regulatory standards and internal procedures.
Qualifications
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.
Strong understanding of US and EU regulatory frameworks and submission processes.
Skills & Competencies
Excellent project management and organizational skills.
Strong financial acumen with the ability to track and manage budgets.
Effective communication and stakeholder management abilities.
Detail-oriented with strong problem-solving skills. xpavfwm
Ability to manage multiple projects in a fast-paced environment.
Nice to Have:
Prior experience with