Regulatory Affairs Manager – Global Clinical Trial Applications

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🕒 April 29

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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.

🎯 Requirements

• 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 • 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

🏖️ Benefits

• Competitive salary • Extensive benefits package focused on health and well-being • Flexible working culture with valued work-life balance • Opportunities for growth and development