Regulatory Affairs Professional
hace 23 horas
We are seeking a highly skilled Sr Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific. As a key member of our Regulatory Liaison team, you will play a critical role in leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.
Key Responsibilities- Regulatory Advice and Project Management: Provides regulatory advice and carries out projects in the provision of regulatory affairs services, including assessment of regulatory documents, preparation and assembly of global regulatory submissions, and QC review of the final submission package.
- Liaison with Stakeholders: Acts as liaison with internal stakeholders in the provision of these services, ensuring seamless communication and collaboration.
- Interface with Project Teams: Interfaces with PPD project teams and Health Authorities regarding regulatory strategy/submission activities, developing and maintaining cooperative working relationships.
- Advisory Role: Advises and directs project team members on their responsibilities relative to regulatory strategy/submission activities, acts as a key liaison between Regulatory Affairs Department and project team for assigned projects.
To be successful in this role, you will need:
- Education: Bachelor's Degree; degree in Pharmacy or Life Science is an advantage.
- Experience: Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered.
- Skills and Abilities: Some regulatory affairs experience is preferable but not mandatory, 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.
Thermo Fisher Scientific is a world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. We value diversity, equity, and inclusion, and we strive to create a workplace that reflects these values.
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