Regulatory Project Manager

Title : Regulatory Project Manager

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.
• Ability to manage multiple projects in a fast-paced environment.

Nice to Have:

• Prior experience with Monday.com