Senior Regulatory Affairs Specialist – Regulatory Liaison

Thermo Fisher Scientific

. Provide regulatory advice and carry out projects in the provision of regulatory affairs services .

Posted 10/8/2026full-timeRemote • CroatiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs, including the preparation and submission of regulatory documents and applications globally. Strong communication skills and the ability to collaborate effectively with project teams and stakeholders are essential.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Regulatory SubmissionsClinical Trials Application CompilationExcellent English Communication SkillsMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document AssessmentQuality-Control ReviewRegulatory Strategy DevelopmentProject Management LiaisonRegulatory Application Processes

Soft Skills

Organizational SkillsProblem Solving SkillsAttention to DetailTeam CollaborationMultitasking Ability

Tools & Technologies

ETMFCTMS

Industry Keywords

PharmacyLife ScienceRegulatory ApplicationsHealth AuthoritiesClinical Trials

About the role

Key responsibilities & impact

Provide regulatory advice and carry out projects in the provision of regulatory affairs services
Act as liaison with internal stakeholders in providing regulatory affairs services
Perform day-to-day operational aspects of the Regulatory Affairs Department, including assessment of regulatory documents
Prepare and assemble global regulatory submissions
Conduct quality-control review of final submission packages
Interface with PPD project teams and Health Authorities regarding regulatory strategy and submission activities
Develop and maintain cooperative working relationships with Project Managers and project team members
Advise and direct project teams on responsibilities related to regulatory strategy and submission activities
Act as key liaison between the Regulatory Affairs Department and project teams for assigned projects

Requirements

What you’ll need

Bachelor's Degree
Degree in Pharmacy or Life Science is an advantage
Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered
Previous Regulatory affairs experience
Appreciation of the requirements, timelines and processes for regulatory applications globally is a valuable asset
Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage
Excellent English language communication skills, both verbal and in writing
Computer skills (Microsoft Office)
Experience in applications used in clinical trials (eTMF, CTMS) would be an advantage
Good organizational and planning skills
Ability for multiple project tasking
Proven ability to work effectively in a team, including in a multinational one
Problem solving skills and strong attention to detail

Benefits

Comp & perks

Fully remote work arrangement
Standard Office Hours (40/wk)