Summary:
Plasma Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities associated with Source Plasma collection within the United States of America, Canada and Rest of World (ROW). This includes activities associated with US Food and Drug Administration (FDA) licensure and registration (biologics (BLA), medical device), Health Canada licensing, Clinical Laboratory Improvement Amendments (CLIA) activities, Plasma Protein Therapeutics Association (PPTA) membership and certification, COLA accreditation, state/province requirements and ROW licensing activities as applicable.
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.
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.
- 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.
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.
- Experience with Adobe PDF.
- Experience 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.
- 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.
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.
