Senior Regulatory Affairs Specialist – Global Clinical Trial Applications
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Anywhere in Europe
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Job Level
About the role
- Prepares and reviews regulatory submissions.
- Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.
- Leads the development and implementation of project-specific processes for sponsors.
- Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
- Provides training and guidance to junior team members as appropriate.
- Participates in project launch meetings, review meetings and project team meetings.
- Supports business development activities, including project budgeting/forecasting.
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Strong English language (written and oral) communication skills as well as local language where applicable
- Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Solid negotiation skills
- Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsregulatory strategyproject budgetingproject forecastingcontract modificationsclinical trial authorizationlicensinglifecycle managementICH guidelinesregulatory affairs procedures
Soft Skills
communication skillsinterpersonal skillsteam collaborationorganizational skillstime managementplanning skillsnegotiation skillstraining and guidanceadaptabilityproblem-solving
Certifications
Bachelor's degreerelevant formal academic qualification