Plasma Regulatory Affairs Associate

Primary 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.
• Escalate to management urgent and time-sensitive matters that impact regulatory compliance.
• 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.

Additional Responsibilities

• Exhibits professional behavior with internal/external business associates, reflecting positively on the company.
• Understands the quality consequences of improper job performance and is aware of potential compliance defects in their 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.

Knowledge, Skills, And Abilities

• Exhibits professional behavior with internal/external business associates, reflecting positively on the company.
• Understands the quality consequences of improper job performance and is aware of potential compliance defects in their 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.

Experience

• With Microsoft Office.
• With Adobe PDF.
• In plasma collection, pharmaceutical industry, or a regulated field.

Education And Experience

• 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.

Occupational Demands

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently sits for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Light to moderate lifting and carrying objects with a maximum lift of 25lbs.
• Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Reliance on oral or written instructions and plans work schedules to meet goals.
• Frequently interacts with others, relates sensitive information to diverse groups.