Sr/Regulatory Affairs Specialist - FSP - EMEA

ThermoFisher Scientific; España; On-site; EUR 32,000 - 52,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist to lead country- and site-level documents required for site activation. You will review essential regulatory documentation for completeness and quality, and communicate findings to the team to support timely activation.

Responsibilities include validating packs, tracking reviews, and staying current with SOPs and regulatory guidelines, while collaborating with colleagues across functions to ensure accuracy and consistency.

Qualifications

• Good English language (written and oral) communication skills as well as local language where applicable.
• Good attention to detail and quality as well as editorial/proofreading skills.
• Good interpersonal skills to work effectively in a team environment.
• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies.
• Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects.
• Good negotiation skills.
• Capable of working independently with direction and exercising independent judgement.
• Bachelor's degree/previous experience comparable to 2+ years

Responsibilities

• Review country essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.
• Review site essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.
• Notifies EDP Submitter via email of review outcome detailing requested revisions and/or corrected documents when deficiencies are noted.
• Review revised packs to ensure deficiencies were resolved and communicate review outcome to the SSU Specialist.
• Tracks EDP review details in the applicable data tracking system.
• Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.

Skills

English language

Attention to detail

Interpersonal skills

Time management

Planning

Negotiation

Independent work

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to serve as the lead over several countries/projects in providing innovative solutions, including regulatory expertise and client interface. As a Regulatory Affairs Specialist, you will be responsible for the review and approval of country- and site-level essential documents required for site activation. The documents required for each study site and country are documented in a study-specific Essential Document Compliance (EDC) Review Checklist. Once final study documents are available, the Regulatory Affairs Specialist reviews all required essential regulatory documentation for completeness, accuracy and quality, ensuring that documentation meets applicable regulatory and study requirements and supports timely site activation.

What You’ll Do:

• Review country essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.

• Review site essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.

• Notifies EDP Submitter via email of review outcome detailing requested revisions and/or corrected documents when deficiencies are noted.

• Review revised packs to ensure deficiencies were resolved and communicate review outcome to the SSU Specialist.

• Tracks EDP review details in the applicable data tracking system.

• Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.

Education and Experience Requirements:

• Good English language (written and oral) communication skills as well as local language whereapplicable

• Good attention to detail and quality as well as editorial/proofreading skills

• Good interpersonal skills to work effectively in a team environment

• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learningnew technologies

• Basic organizational, time management, and planning skills to create and follow timelines, conductlong-range planning, adapt to changing priorities and handle multiple projects

• Good negotiation skills

• Capable of working independently with direction and exercising independent judgement

• Bachelor's degree/previous experience comparable to 2+ years

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.