Principal Regulatory Affairs Professional

Thermo Fisher Scientific

. Provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization .

Posted 10/6/2026full-timeRemote • Chile, Mexico, Brazil, Colombia, Peru, ArgentinaLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory intelligence and strategy, with a strong understanding of ICH guidelines and global regulatory affairs. Capable of managing multiple projects while ensuring compliance with local, regional, and international standards.

Highest-signal resume keywords

Regulatory Strategy DevelopmentProject ManagementICH Guidelines ExpertiseRegulatory Document ReviewClient Liaison and Communication

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory AffairsClinical Trial AuthorizationLicensing ProceduresQuality AssuranceStatistical ConceptsMedical TerminologyBudgeting and ForecastingDocument PreparationPerformance Review InputRegulatory SOPs

Soft Skills

Attention to DetailInterpersonal SkillsOrganizational SkillsProblem-Solving SkillsNegotiation Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Preclinical DevelopmentClinical DevelopmentCMCRegulatory SubmissionsRegulatory Compliance

About the role

Key responsibilities & impact

Provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization
Prepare client deliverables meeting local, regional, and ICH regulatory and technical requirements
Act as liaison with internal and external clients in the provision and marketing of regulatory services
Review regulatory documents and submissions to ensure high quality standards and compliance with client, local, and regional requirements
Advise internal and external clients on regulatory strategy and provide up-to-date legislation and guidance
Participate in project management activities supporting regulatory services
Provide matrix/project leadership, training, and guidance to junior team members
Provide input on performance reviews to management
Ensure adherence to project budgets, schedules, scope of work, organizational and regulatory SOPs, and WPDs
Contribute to business development activities, including project budgeting and forecasting
Occasionally drive to site locations and travel domestically and internationally

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
8+ years of previous experience providing the knowledge, skills, and abilities to perform the job
An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
Excellent English language written and oral communication skills, as well as local language where applicable
Excellent attention to detail, quality, editorial, and proofreading skills
Strong interpersonal, organizational, time management, planning, negotiation, analytical, investigative, problem-solving, and independent judgment skills
Strong computer skills, including Microsoft Word, Excel, and PowerPoint, and ability to learn new technologies
Ability to manage multiple projects, changing priorities, timelines, budgets, and forecasts
Strong understanding of global, regional, and national regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management
Expert knowledge of ICH and other global regulatory guidelines
Good understanding of regulatory specialty areas such as preclinical, clinical, CMC, and publishing
Strong understanding of medical terminology, statistical concepts, and guidelines

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule