Clinical Trial Regulatory Affairs Specialist

Há 11 horas


Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

About the Role

We are seeking a Clinical Trial Regulatory Affairs Specialist to join our global Regulatory Affairs department – Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.

Job Description

In this role, you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects.

You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.

You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.

You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.

Key Responsibilities

  • Preparation and assembly of global regulatory submissions
  • Interacting with sponsors
  • Review and assess clinical trial regulatory documents
  • Review and assess scientific literature
  • Manage project teams and preparation
  • Participate in launch meetings, review meetings and project team meetings

Requirements

Education: Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification
Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job
KSA: Excellent command of the English language (written and oral) as well as local language where applicable
Excellent attention to detail and quality as well as excellent editorial/proofreading skills
Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Advanced computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologies
Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables
Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
Excellent analytical, investigative and problem-solving skills

Benefits

A competitive salary ($85,000 - $110,000 per year), flexible working culture, and extensive benefits package based around the health and well-being of our employees.



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