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Global Regulatory Compliance Manager

hace 1 semana

Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completo
Position Overview:

We are seeking a skilled Regulatory Affairs professional to fill the role of North American Regulatory Affairs Lead. This is an exciting opportunity to join our team and contribute to the success of our organization.

As a key member of our regulatory affairs team, you will be responsible for providing innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical requirements.

Main Responsibilities:
  • Support the preparation of documentation and submissions under guidance.
  • Coordinate and manage client deliverables ensuring regulatory compliance.
  • Liaise with internal and external clients to track and update the status of long-range planning, adapting to changing priorities and handling multiple projects.

Required Skills:
  • Excellent communication and negotiation skills.
  • Basic understanding of the regulatory landscape and procedures.
  • Strong organizational and time management skills.