Regulatory Affairs Specialist
hace 5 días
Thermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for leading on communications with regulatory agencies as part of centralized regulatory submissions, including the EU CTR process.
Key Responsibilities:- Provide regulatory advice and carry out projects in the provision of regulatory affairs services.
- Act as liaison with internal stakeholders in the provision of these services.
- Work with the Regulatory Affairs Management to perform the day-to-day operational aspects of the Department, including assessment of regulatory documents, preparation and assembly of global regulatory submissions, and QC review of the final submission package.
- Interface with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.
- Develop and maintain a cooperative working relationship with Project Managers and project team members for assigned projects.
- Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities.
- Act as a key liaison between Regulatory Affairs Department and project team for assigned projects.
- 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.
- An appreciation of the requirements, timelines and processes for regulatory applications globally is a valuable asset.
- 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) and 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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