Regulatory Affairs Lead: Site Activation & Compliance

ThermoFisher Scientific; España; Sur place; EUR 32 000 - 52 000; Plein temps

Résumé du poste

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

Responsabilités

• 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.

Connaissances

English language

Attention to detail

Interpersonal skills

Time management

Planning

Negotiation

Independent work

Formation

Bachelor's degree

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Description du poste

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.