Senior Regulatory Affairs Specialist - FSP - EMEA

Thermo Fisher Scientific

. Serve as lead over several countries/projects, providing regulatory expertise and client interface .

Posted 9/15/2026full-timeRemote • BulgariaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in regulatory compliance and document review processes, ensuring accuracy and quality in essential documents while effectively communicating outcomes and managing multiple projects. Proficient in utilizing data tracking systems and maintaining knowledge of relevant SOPs and regulatory guidelines.

Highest-signal resume keywords

Regulatory ExpertiseDocument ReviewData TrackingCommunication SkillsAttention to Detail

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

Document Compliance ReviewRegulatory Guidelines KnowledgeData Tracking SystemsMicrosoft WordMicrosoft ExcelMicrosoft PowerPoint

Soft Skills

Interpersonal SkillsNegotiation SkillsOrganizational SkillsTime ManagementAttention to Detail

Industry Keywords

Essential DocumentsSite ActivationSOPsClient Directives

About the role

Key responsibilities & impact

Serve as lead over several countries/projects, providing regulatory expertise and client interface
Review country-level essential documents for completeness, accuracy, and quality according to the study-specific Essential Document Compliance checklist
Review site-level essential documents for completeness, accuracy, and quality
Notify the EDP Submitter by email of review outcomes, requested revisions, and corrected documents when deficiencies are identified
Review revised document packs to ensure deficiencies are resolved
Communicate review outcomes to the SSU Specialist
Track EDP review details in the applicable data tracking system
Maintain knowledge of SOPs, client SOPs/directives, and current regulatory guidelines
Support timely site activation

Requirements

What you’ll need

Good English language (written and oral) communication skills, as well as local language where applicable
Good attention to detail and quality
Editorial/proofreading skills
Good interpersonal skills to work effectively in a team environment
Good computer skills, including Microsoft Word, Excel, and PowerPoint
Ability to learn new technologies
Basic organizational, time management, and planning skills
Ability to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects
Good negotiation skills
Ability to work independently with direction and exercise independent judgment
Bachelor's degree or previous experience comparable to 2+ years

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule