Regulatory Affairs Associate – Entry Level

Responsibilities

• Accurately prepare regulatory applications required by federal and other regulatory authorities.
• Research internal documents, complete applications, and forms; prepare cover letters and summaries.
• Submit and monitor application submission for timely review and acceptance.
• 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.
• Educate and inform internal customers regarding regulatory requirements.
• Assist with evaluation of regulatory changes for impact to the business.

• 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.
• Experience with Microsoft Office.
• Experience with Adobe PDF.
• Experience in plasma collection, pharmaceutical industry, or a regulated field.