Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

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 general 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.

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