Regulatory Affairs Manager (Global Clinical Trial Applications)

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