Join us at Thermo Fisher Scientific as a Regulatory Affairs Lead - FSP. Our Global Regulatory Affairs team is expanding, and we are looking for a clinical expert to support clinical trial new indications, including early and late development stages. Experience with EU CTR and global regulatory environments is preferred.
The Regulatory Affairs Lead will oversee multiple countries/projects, providing strategic regulatory guidance, ensuring compliance with local, regional, and international regulations, and acting as the main liaison with clients. Responsibilities include reviewing regulatory documents, advising on regulatory strategy, supporting project management, mentoring junior staff, and contributing to business development.
Qualifications:
* Bachelor's degree or equivalent with 8+ years of relevant experience.
* Excellent communication skills in English; proficiency in local languages is a plus.
* Strong knowledge of global/regional/national regulatory requirements, including ICHand EU Clinical Trial Regulation.
* Experience with clinical trial applications and submissions.
* Leadership skills and ability to manage multiple projects effectively.
We offer a competitive salary, extensive benefits, flexible working culture, and a collaborative environment committed to making a positive impact on health and safety worldwide.
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