Regulatory Affairs Associate, Plasma (Entry Level)

Grifols, S.A; North Carolina; On-site; USD 52,000 - 76,000; Full time

Job summary

Grifols, S.A in RTP, NC is seeking an entry level Regulatory Affairs Associate to support licensing, surveillance, and regulatory activities for US, Canada, and ROW. You will assist with FDA licensure, CLIA, and COLA compliance while coordinating documents and timelines.

The role emphasizes accuracy, organization, and collaboration with cross-functional teams to ensure timely submissions and ongoing compliance in a fast-paced plasma-derived medicines environment.

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.
• 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 the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

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 in a manner to facilitate the review process.
• Submit and monitor application submission for timely review and acceptance with the ability to respond to regulatory agency inquiries.
• Provide updates to management on the status of applications.
• Maintain files contemporaneously 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 the details of pertinent conversations and/or written interactions with a regulatory authority, when applicable.
• Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.
• Provide registration and licensing documentation to stakeholders in a timely manner.
• Assist with evaluation of regulatory changes for impact to the business.
• Process and track all invoices to ensure prompt payment associated with licensing activities.

Skills

Microsoft Office

Adobe PDF

Plasma industry experience

Regulated field experience

Education

Bachelor's Degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology)

Job description

Grifols, S.A in RTP, NC is seeking an entry level Regulatory Affairs Associate to support licensing, surveillance, and regulatory activities for US, Canada, and ROW. You will assist with FDA licensure, CLIA, and COLA compliance while coordinating documents and timelines.

The role emphasizes accuracy, organization, and collaboration with cross-functional teams to ensure timely submissions and ongoing compliance in a fast-paced plasma-derived medicines environment.