Regulatory Documentation Specialist I

Jobtailor; Clayton (NC); On-site; USD 40,000 - 55,000; Full time

Job summary

Jobtailor is seeking a Regulatory Affairs support professional to maintain regulatory documentation and filing systems for the Biopharma North America regulatory team in Clayton, North Carolina.

You will update records, coordinate SME reviews, assist with SOPs/IBPs, manage translations with vendors, and respond to record requests through diligent research and review.

Qualifications

• 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.

Responsibilities

• Maintains regulatory documentation and filing systems in support of the Biopharma North America regulatory team.
• Performs updates, facilitates SME reviews, and ensures proper hard copy and electronic filing of Regulatory Submission Documents (RSDs).
• Assists in maintaining SOPs/IBPs that describe the Regulatory Affairs filing system and other RA SOPs/IBPs files and maintenance.
• Manages requests for translations and legalizations with vendors.
• Responds to requests for records by researching and reviewing internal documentation.

Skills

Regulatory documentation

Filing systems

Vendor coordination

Education

Bachelor's degree or equivalent

Job description

Responsibilities

• Maintains regulatory documentation and filing systems in support of the Biopharma North America regulatory team.
• Performs updates, facilitates SME reviews, and ensures proper hard copy and electronic filing of Regulatory Submission Documents (RSDs).
• Assists in maintaining SOPs/IBPs that describe the Regulatory Affairs filing system and other RA SOPs/IBPs files and maintenance.
• Manages requests for translations and legalizations with vendors.
• Responds to requests for records by researching and reviewing internal documentation.

Requirements

• 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.

Core Competencies

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.