Regulatory Affairs Lead for North American Operations

hace 3 días


Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo
Job Overview

We are seeking a highly skilled Regulatory Affairs Lead to oversee the preparation and submission of regulatory documentation in North America. The successful candidate will provide innovative regulatory solutions, ensuring compliance with current local, regional, and ICH requirements.

About Thermo Fisher Scientific

Thermo Fisher Scientific is a global leader in scientific research and healthcare products. Our company values innovation, collaboration, and excellence.

Responsibilities
  • Regulatory Compliance: Ensure that client deliverables meet current local, regional, and ICH regulatory and technical requirements.
  • Submission Preparation: Oversee the preparation and submission of regulatory documentation, including IRB submissions.
  • Liaison and Communication: Act as a liaison with internal and external clients, coordinating and managing client deliverables.
Requirements

The ideal candidate will possess excellent communication and negotiation skills, a basic understanding of the regulatory landscape, and relevant formal academic or vocational qualifications. Previous experience in regulatory affairs is essential, with at least 5+ years of comparable experience.

A bachelor's degree or equivalent is required, and proficiency in Microsoft Office is necessary. Strong organizational, time management, and planning skills are also required, as well as good analytical, investigative, and problem-solving skills.

What We Offer

As a member of our team, you will enjoy a competitive salary range of $120,000 - $180,000 per year, depending on experience. This role requires a highly organized individual with strong regulatory expertise and the ability to manage multiple projects and adapt to changing priorities.



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