Principal Regulatory Affairs Specialist – Regulatory Liaison
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Job Description
Principal Regulatory Affairs Specialist advising global regulatory submissions for Thermo Fisher Scientific. Liaising with project teams and health authorities across clinical-trial programs.
Responsibilities:
- Provides regulatory advice and carries out projects in the provision of regulatory affairs services
- Acts as liaison with internal stakeholders in the provision of regulatory affairs services
- Performs day-to-day operational aspects of the Regulatory Affairs Department, including assessment of regulatory documents, preparation and assembly of global regulatory submissions, and QC review of final submission packages
- Interfaces with PPD project teams and Health Authorities regarding regulatory strategy and submission activities
- Develops and maintains cooperative working relationships with Project Managers and project team members for assigned projects
- Advises and directs project teams regarding responsibilities related to regulatory strategy and submission activities
- Acts as a key liaison between the Regulatory Affairs Department and project teams for assigned projects
Requirements:
- Bachelor's Degree; degree in Pharmacy or Life Science is an advantage
- Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered
- Some regulatory affairs experience is preferable but not mandatory
- Appreciation of requirements, timelines and processes for regulatory applications globally
- Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage
- Excellent English language communication skills, both verbal and in writing
- Computer skills (Microsoft Office)
- Experience in applications used in clinical trials (eTMF, CTMS) would be an advantage
- Good organizational and planning skills
- Ability for multiple project tasking
- Proven ability to work effectively in a team, including in a multinational one
- Problem solving skills and strong attention to detail
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