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

📌 Regulatory Project Manager (Varese)
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