Global Regulatory Strategy Lead

ThermoFisher Scientific; México; Remote; MXN 900,000 - 1,500,000; Full time

Job summary

ThermoFisher Scientific is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for multiple countries and projects. You will provide expert regulatory intelligence supporting product development from preclinical stages through registration and optimization.

You will act as a liaison with internal and external clients, ensuring compliant, timely deliverables and strategic guidance across ICH/global guidelines.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 8+ years of relevant experience in regulatory affairs or related field.

Responsibilities

• Provide senior regulatory review of documents and submissions to ensure high-quality outcomes.
• Offer regulatory strategy guidance to internal and external clients on projects of moderate complexity.
• Support project management and liaise with clients to market regulatory services.
• Lead and mentor junior team members on regulatory matters and timelines.
• Ensure adherence to budgets, timelines, and scope of work.
• Support budgeting and forecasting for regulatory projects.

Skills

English proficiency

Attention to detail

Interpersonal skills

Regulatory knowledge

Project management

Education

Bachelor's degree or equivalent

8+ years experience

Tools

Microsoft Word

Excel

PowerPoint

Job description

ThermoFisher Scientific is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for multiple countries and projects. You will provide expert regulatory intelligence supporting product development from preclinical stages through registration and optimization.

You will act as a liaison with internal and external clients, ensuring compliant, timely deliverables and strategic guidance across ICH/global guidelines.