Regulatory Affairs Associate (entry level)

About the Role

Grifols is a global healthcare company focused on plasma-derived medicines and transfusion medicine. The Plasma Regulatory Affairs Associate will monitor and perform administrative activities for existing licenses in compliance with US FDA, CLIA, PPTA, and COLA requirements to meet business objectives.

Key Responsibilities

• Accurately prepare regulatory applications required by federal and other regulatory authorities, as well as industry affiliates for review prior to application submission.
• Research internal documents, complete applications, and forms; prepare cover letters and summaries; assemble and format applications to facilitate the review process.
• Submit and monitor application submissions for timely review and acceptance, and respond to regulatory agency inquiries.
• Provide management with updates on application status.
• Escalate urgent and time-sensitive matters impacting regulatory compliance to management.
• Maintain contemporaneous files for transparency and timelines.
• Maintain applicable shared mailboxes, dashboards, and accounts related to administrative licensing activities.
• Archive and distribute applications electronically and in hardcopy.
• Record details of pertinent conversations and/or written interactions with regulatory authorities, when applicable.
• Educate and inform internal customers at the corporate office and plasmapheresis centers regarding regulatory requirements for licensing activities.
• Provide registration and licensing documentation to stakeholders in a timely manner.
• Assist with the evaluation of regulatory changes for business impact.
• Process and track all invoices associated with licensing activities to ensure prompt payment.
• Exhibit professional behavior with internal/external business associates, reflecting positively on the company.
• Understand the quality consequences of improper job performance and be aware of potential compliance defects in the area of responsibility.
• Interface with various levels and groups throughout the organization.
• Manage multiple tasks with competing demands and deadlines.
• Assist with department-related projects, goals, and/or objectives.
• Perform other duties as required.

Requirements & Tech Stack

• Microsoft Office
• 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 the pharmaceutical or blood industry.
• Note: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of stated requirements.