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Join Thermo Fisher Scientific’s Regulatory Affairs team to drive scientific and regulatory innovation that supports the development of life-changing therapies. In this role, you will ensure that clinical research projects align with regulatory compliance, support product development, and provide critical documentation from preclinical phases through registration.
Key Responsibilities
- Assist in preparing regulatory documentation and submissions under guidance.
- Coordinate and manage client deliverables to ensure regulatory compliance.
- Liaise with internal/external clients to track project plans and update project statuses.
- Support budgeting/forecasting for regulatory projects.
- Maintain knowledge of SOPs, ICH guidelines, and other regulatory frameworks.
- Assist in business development and project pricing for the department.
- Identify client needs concerning timelines, quality, and delivery goals.
- Engage with project team members to resolve barriers and ensure smooth project execution.
Requirements
Education:
- Bachelor’s degree or equivalent qualification in a relevant field.
Experience:
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- 2+ years of relevant experience in regulatory affairs or clinical research services.
Skills and Abilities:
- Strong written and verbal communication skills in English (and local languages if applicable).
- Attention to detail and proficiency in editorial/proofreading.
- Strong interpersonal skills to collaborate in a team environment.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Good organization, time management, and planning skills to handle multiple projects efficiently.
- Negotiation skills and ability to assess sponsor needs and deliver regulatory solutions.
- Basic understanding of global and national regulatory frameworks (e.g., clinical trial authorization, licensing, and lifecycle management).
- Knowledge of medical terminology, statistical concepts, and relevant guidelines.
Work Schedule
- Monday to Friday (Standard Work Hours).
- Hybrid Remote with flexibility to work from the office as needed.
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