Clinical Trial Reg Affairs Principal Assistant

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Join Us as a Principal Regulatory Affairs Assistant - Make an Impact at the Forefront of Innovation

The Principal Regulatory Affairs Assistant provides advanced administrative and operational support to the Reg Affairs department.

What You'll Do:

• Provide administrative support to department and/or project teams.
• Provide project specific services, documentation and coordination of projects and supports

reporting of same to management, internal and external clients.

• Support the Regulatory project team in coordinating and managing client deliverables to ensure compliance with SOPs.
• Support the preparation of documentation and submissions related to them under guidance.
• Electronically compile submissions.
• Track documents and submissions in internal or sponsor systems as required.
• File submission related documents as per internal or Sponsor SOP as applicable.
• Liaise with internal clients to track and provide status updates of project deliverables

Education & Experience Requirements:

• High school / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).
• 3+ years’ experience in bid preparation and/or the development and fulfillment of contracts and RFP requirements is preferred

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

• Excellent organizational and planning skills to effectively manage shifting priorities
• Strong understanding of contractal and proposal documents
• Capable of working effectively on a team and/or independently with minimal supervision
• Excellent electronic document production skills
• Excellent proficiency in several computer applications including Microsoft Office software
• Exceptional attention to detail and quality of documentation
• Outstanding interpersonal skills with the ability to interact with customers
• Excellent verbal and written communication skills
• Capable of multitasking and working under pressure
• First-rate analytical, business and math skills.

Working Conditions and Environment:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential occasional travel required.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.