Work Schedule Standard (Mon-Fri) Environmental Conditions Office Join Us as a Regulatory Affairs Manager As a Regulatory Affairs Manager, you’ll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization.

The Regulatory Affairs

Lead (RAL) will own regulatory decision-making for the assigned clinical program and drive the cross-functional clinical trial team toward execution of the regulatory strategy and achievement of program objectives . Working closely with Clinical Operations and other key functions, the RAL will drive alignment, accountability, and execution across the clinical trial team , ensuring regulatory requirements and dependencies are understood and incorporated into operational plans. The RAL is expected not only to provide regulatory advice, but also to actively lead the team through regulatory challenges and decisions to maintain progress against agreed study milestones and strategic objectives.

Own regulatory decision-making for assigned clinical trials and programs, ensuring decisions are consistent with the agreed indication-level regulatory strategy. Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders on projects of moderate to high complexity. Maintain current knowledge of applicable legislation, regulatory requirements, guidelines, and emerging regulatory developments and translate these into relevant strategic and operational guidance.

Serve as a regulatory subject-matter expert across global, regional, and country-specific requirements. Partner closely with Clinical Operations and other functions to integrate regulatory requirements, dependencies, risks,



and timelines into study operational plans. Establish clear regulatory priorities and accountabilities across the clinical trial team and proactively identify issues that could affect regulatory deliverables or study milestones.

Participate in launch meetings, project reviews, governance discussions, and project team meetings.

Regulatory

Submissions & Compliance Lead the development and execution of global regulatory strategies and preparation of submissions to Regulatory Authorities and Ethics Committees, ensuring high-quality standards and compliance with applicable local, regional, and global requirements. Ensure compliance with applicable organizational and regulatory SOPs, WPDs, policies, and procedures. Project & Client Management Ensure quality performance across assigned and managed projects.

Manage project budgets and forecasting activities. Identify out-of-scope activities in a timely manner and collaborate with relevant departments to support contract modifications and associated follow-through. Collaborate with Business Development on pricing and new-business opportunities, including client presentations and development of proposal text, scope, and budgets.

Provide matrix/project leadership, coaching, training, and guidance to junior team members.

Education &

Experience Bachelor’s degree or equivalent relevant formal academic/vocational qualification. Typically 9+ years of relevant experience providing the knowledge, skills, and abilities required to perform the role.



An equivalent combination of appropriate education, training, and directly related experience may be considered. Excellent written and verbal English communication skills, as well as local-language capability where applicable. Demonstrated ability to make and own regulatory decisions, balancing regulatory requirements, strategic objectives, operational feasibility, risk, and timelines.

Experience with Platform Protocols and Integrated Protocol Designs highly desirable Exceptional interpersonal and stakeholder-management skills, including the ability to work effectively with clients, Clinical Operations, project teams, and other functional stakeholders. Excellent negotiation and conflict-resolution skills. Ability to work independently and exercise sound judgment in assessing regulatory needs and directing project teams toward compliant, pragmatic solutions.

Excellent understanding of global, regional, and national regulatory requirements and procedures relating to clinical trial authorization, licensing, registration, and lifecycle management. Strong understanding of medical terminology, statistical concepts, and relevant scientific and regulatory guidelines. Strong organizational, planning, and time-management capabilities, including the ability to manage competing priorities and multiple complex projects.

Excellent attention to detail, quality, editorial review, and proofreading skills. Excellent understanding of project budgeting and forecasting. Advanced proficiency with Microsoft Word, Excel, and PowerPoint and the ability to learn and adopt new technologies.

Work is primarily performed in an office environment with standard office equipment. Occasional travel to site locations may be required, including domestic and international travel.

📌 Regulatory Affairs Manager /Senior Manager (Milano)
🏢 Thermo Fisher Scientific
📍 Milano