Regulatory Affairs Manager (Global Clinical Trial Applications)

ThermoFisher Scientific; Roma; Ibrido; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

Global environment

Growth opportunities

Descrizione del lavoro

Thermo Fisher Scientific in Italy is seeking a Regulatory Affairs Manager to lead global regulatory submissions and top-tier client engagements. You will coordinate strategies for Phase 1–4 trials, ensuring regulatory compliance and timely delivery in a fast-paced, international environment.

You will mentor teams, manage budgets, and work with business development on proposals. Strong English skills and robust regulatory knowledge are essential for success in this senior role.

Competenze

• Bachelor’s degree or advanced degree in life sciences.
• 9+ years of regulatory or clinical trial experience.
• Proven project management and client-facing experience.

Mansioni

• Lead the preparation of global regulatory submissions for CTA and ensure high quality standards that meet local and regional requirements.
• Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity.
• Provide oversight across multiple studies/projects, ensuring alignment of regulatory strategy, quality, and delivery.
• Act as a senior client-facing lead, contributing to broader regulatory planning and supporting proposals, bid defenses, and scope discussions.
• Ensure quality performance for key/managed projects.
• Manage project budgeting/forecasting functions and maintain accountability for financial and scope management.
• Identify and recognize out-of-scope activities and partner with relevant teams to manage contract modifications.
• Collaborate with business development in pricing and securing new business by contributing to proposals, budgets, and client presentations.
• Provide matrix/project leadership and guidance to team members.
• Ensure compliance with relevant organizational and regulatory SOPs and WPDs.
• Participate in launch meetings, review meetings, and project team meetings.

Conoscenze

Regulatory strategy

Client-facing

Budgeting

Project management

English proficiency

Formazione

Bachelor’s degree or advanced degree in life sciences

Strumenti

Microsoft Word

Excel

PowerPoint

Descrizione del lavoro

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life—enabling our customers to make the world healthier, cleaner and safer. With clinical trials conducted in 100+ countries and ongoing development of innovative frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.

We are currently seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department, Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.

In this role, you will be part of a global team providing innovative regulatory solutions, owning regulatory affairs responsibilities, and leading discussions with internal and external clients. You will coordinate global regulatory strategies on assigned (Phase 1–4) clinical trials, studies, and projects, supporting clients with strategic regulatory intelligence and guidance throughout clinical development.

Role Focus at This Level

• This position sits within our senior individual contributor framework

• In this Manager role, the emphasis is on oversight across multiple projects, client engagement, and accountability for delivery, scope, and financial elements .

Responsibilities

• Lead the preparation of global regulatory submissions for CTA and ensure high quality standards that meet local and regional requirements.

• Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity.

• Provide oversight across multiple studies/projects , ensuring alignment of regulatory strategy, quality, and delivery.

• Act as a senior client-facing lead , contributing to broader regulatory planning and supporting proposals, bid defenses, and scope discussions.

• Ensure quality performance for key/managed projects.

• Manage project budgeting/forecasting functions and maintain accountability for financial and scope management .

• Identify and recognize out-of-scope activities and partner with relevant teams to manage contract modifications.

• Collaborate with business development in pricing and securing new business by contributing to proposals, budgets, and client presentations.

• Provide matrix/project leadership and guidance to team members.

• Ensure compliance with relevant organizational and regulatory SOPs and WPDs.

• Participate in launch meetings, review meetings, and project team meetings.

Qualifications

Education and Experience:

• Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9+ years)

• Proven project management experience and experience performing effectively in a client-facing role

Knowledge, Skills and Abilities

• Strong understanding of global/regional regulatory requirements and ICH guidelines

• Excellent analytical, investigative, and problem-solving skills

• Solid understanding of budgeting and forecasting

• Excellent English language (written and oral) communication skills as well as local language where applicable

• Excellent attention to detail and quality, with strong editorial/proofreading skills

• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments

• Advanced computer skills including Microsoft Word, Excel, and PowerPoint

• Strong organizational, time management, and planning skills

• Excellent negotiation skills

What We Offer

As well as being rewarded with a competitive salary, we offer an extensive benefits package focused on health and well-being. We provide a flexible working culture where work-life balance is valued, alongside a collaborative global environment with opportunities for growth and development.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values—Integrity, Intensity, Innovation, and Involvement—working together to accelerate research and support patients in need.

#LI-AS3

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.