Regulatory Affairs Lead

hace 4 días


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

The Regulatory Affairs Lead for North America at Thermo Fisher Scientific plays a pivotal role in ensuring compliance with local, regional, and ICH regulatory requirements. This dynamic professional provides innovative solutions to support product development from preclinical stages through registration and optimization.

Key Responsibilities:
  • Provides senior review and advice to prepare regional regulatory submissions, adhering to high-quality standards that meet or exceed client expectations.
  • Serves as a subject matter expert, offering regulatory strategy advice and technical expertise to internal and external clients on key projects of moderate to high complexity.
  • Evaluates quality performance for managed projects, manages project budgeting/forecasting functions, and identifies out-of-scope activities in contracts.
  • Collaborates with business development in pricing and securing new business through presentations and proposal development.
  • Mentors junior team members, providing guidance and training.
Additional Tasks:
  • Oversees all submission types to Regulatory Authorities and/or EC/local submissions, including North America IRB submissions.


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