Global Plasma Regulatory Affairs Specialist

Grifols; North Carolina; On-site; USD 65,000 - 90,000; Full time

Job summary

Grifols Plasma Regulatory Affairs team seeks an associate to oversee licensing, surveillance, and regulatory activities for Source Plasma in the US, Canada, and ROW. Responsibilities include preparing applications, ensuring compliance with FDA/CLIA/PPTA requirements, and maintaining documentation for licensing.

The role requires a scientific degree and 2+ years in regulatory work, with experience in regulated environments and proficiency in Microsoft Office and Adobe PDF.

Qualifications

• Bachelor's Degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology).
• Preferred two (2) years related technical and/or regulatory experience in pharmaceutical or blood industry.
• Equivalency could include 8 years of experience with an Associate's degree or 2 years with a Master’s degree.

Responsibilities

• Prepare regulatory applications required by federal and other regulatory authorities.
• Research internal documents, complete applications, and forms; assemble and format applications for review.
• Submit and monitor application submissions for timely review and acceptance; respond to inquiries.

Skills

Microsoft Office

Adobe PDF

Regulated field

Multitasking

Communication

Education

Bachelor's degree in a scientific discipline

2 years regulatory experience

Job description

Grifols Plasma Regulatory Affairs team seeks an associate to oversee licensing, surveillance, and regulatory activities for Source Plasma in the US, Canada, and ROW. Responsibilities include preparing applications, ensuring compliance with FDA/CLIA/PPTA requirements, and maintaining documentation for licensing.

The role requires a scientific degree and 2+ years in regulatory work, with experience in regulated environments and proficiency in Microsoft Office and Adobe PDF.