Plasma Regulatory Affairs Specialist

Grifols, S.A; North Carolina, United States, Northern America, Americas; Hybrid; USD 65,000 - 90,000; Full time

Job summary

Grifols, S.A is seeking a Plasma Regulatory Affairs Associate to oversee licensing and regulatory activities across the United States, Canada and ROW. The role ensures compliance with FDA, CLIA, PPTA and COLA requirements, supporting plasma collection programs and related registrations.

The associate will prepare applications, manage submissions, coordinate with internal teams and respond to agency inquiries, while maintaining accurate records and communicating status to leadership.

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.

Responsibilities

• Accurately prepare regulatory applications for federal and other regulatory authorities, as well as industry affiliates for review prior to submission.
• Research internal documents, complete applications, and forms; assemble and format applications for review.
• Submit and monitor application submissions for timely review and respond to regulatory inquiries.
• Provide updates to management on the status of applications.
• Escalate urgent regulatory matters to management.
• Maintain files and dashboards related to licensing activities.
• Archive and distribute applications electronically and in hardcopy.
• Record pertinent conversations with regulatory authorities when applicable.
• Educate internal customers on regulatory requirements for licensing activities.
• Assist with evaluation of regulatory changes for impact to the business.
• Process and track invoices associated with licensing activities.

Skills

Microsoft Office

Adobe PDF

Regulated industry experience

Education

Bachelor's degree in a scientific discipline

Tools

Adobe PDF

Microsoft Office

Job description

Grifols, S.A is seeking a Plasma Regulatory Affairs Associate to oversee licensing and regulatory activities across the United States, Canada and ROW. The role ensures compliance with FDA, CLIA, PPTA and COLA requirements, supporting plasma collection programs and related registrations.

The associate will prepare applications, manage submissions, coordinate with internal teams and respond to agency inquiries, while maintaining accurate records and communicating status to leadership.