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Grifols

Regulatory Documentation Specialist I

Grifols

Regulatory Documentation Specialist maintaining regulatory documentation and filing systems. Supporting Biopharma North America regulatory team with submissions and internal documentation.

Posted 7/18/2026full-timeClayton • North Carolina • 🇺🇸 United StatesJuniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in maintaining regulatory documentation and filing systems, with a focus on Regulatory Submission Documents and Standard Operating Procedures. Capable of managing vendor requests and responding to record inquiries through thorough research and review.

Highest-signal resume keywords
Regulatory Documentation ManagementRegulatory Submission DocumentsStandard Operating ProceduresVendor ManagementResearch and Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory AffairsDocumentation FilingSOP MaintenanceTranslation ManagementRecord Keeping
Industry Keywords
BiopharmaPharmaceutical IndustryBlood IndustryRegulatory Compliance

About the role

Key responsibilities & impact
  • Maintains regulatory documentation and filing systems in support of the Biopharma North America regulatory team.
  • Performs updates, facilitate SME reviews, and ensure proper hard copy and electronic filing of Regulatory Submission Documents (RSDs).
  • Assist in maintaining SOPs/IBPs that describe the Regulatory Affairs filing system and other RA SOPs/IBPs files and maintenance.
  • Manage requests for translations and legalizations with vendors.
  • Respond to requests for records by researching and reviewing internal documentation.

Requirements

What you’ll need
  • Bachelor's degree in a relevant discipline, or equivalent work experience.
  • 0 to 1 year of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience.

Benefits

Comp & perks
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements