Global Regulatory Affairs Lead – Site Activation

ThermoFisher Scientific; France; Remote; EUR 55,000 - 75,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist to lead country- and site-level regulatory activities for site activation. You will review essential documents, ensure compliance with regulatory guidelines, and coordinate with global teams to support timely submissions.

Responsibilities include reviewing country/site documents, communicating deficiencies, maintaining up-to-date SOP knowledge, and contributing to project timelines.

Qualifications

• Bachelor's degree or equivalent experience with 2+ years.
• Strong English communication skills (written and spoken) and local language if applicable.
• Excellent attention to detail and editorial skills.
• Solid interpersonal and teamwork abilities.
• Proficient in Word, Excel and PowerPoint; able to learn new tools.
• Ability to manage timelines and multi-project coordination.
• Strong negotiation skills and independent judgment.

Responsibilities

• Review country essential documents for completeness, accuracy, and quality.
• Review site essential documents for completeness, accuracy, and quality.
• Notify EDP Submitter of review outcomes and requested revisions.
• Review revised packs to ensure deficiencies are resolved and communicate outcomes.
• Track EDP review details in the data tracking system.
• Maintain knowledge of SOPs and current regulatory guidelines.

Skills

English communication

Attention to detail

Interpersonal skills

Office software proficiency

Time management

Negotiation skills

Independent judgment

Teamwork

Education

Bachelor's degree or equivalent experience (2+ years)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist to lead country- and site-level regulatory activities for site activation. You will review essential documents, ensure compliance with regulatory guidelines, and coordinate with global teams to support timely submissions.

Responsibilities include reviewing country/site documents, communicating deficiencies, maintaining up-to-date SOP knowledge, and contributing to project timelines.