This is a Hybrid position based out of our Raleigh, NC office.

Summary:

Determine and execute actions necessary for BLA License supplements and other regulatory submissions to ensure that Grifols Plasma Operations is in compliance with federal, state, and local licensing and other regulatory requirements, and that business objectives are met.

Primary Responsibilities:

• Compile and process regulatory submissions through coordination with other departments and research of internal documentation including: completing applications and forms; composing cover letters and summaries; assembling, formatting and packaging submissions in a manner to facilitate the review process; submitting and tracking submissions and providing updates on status; filing, archiving and distributing submissions electronically and in hardcopy.
• Communicate with agencies to monitor registration activity, obtain clarification regarding regulatory requirements, and discuss and determine strategies for regulatory filing
• Assist in preparing responses to regulatory agency inquiries
• Maintain files of all interactions with all agencies
• Communicate with internal customers at headquarters and at the plasmapheresis centers regarding regulatory requirements
• Perform other duties as required

Knowledge, Skills, and Abilities:

• Basic knowledge of applicable laws and regulations.
• Ability to work with limited supervision and initiate contacts essential to submission preparation
• Ability to manage multiple and possibly conflicting priorities.
• Ability to work as part of the regulatory team to meet group objectives
• Ability to review a document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures
• Ability to clearly communicate verbally and in writing
• Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications
• Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents
• Ability to work with other computer systems for filing and tracking supplements and reports
• Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives

Education and Experience:

• Bachelor’s degree in relevant discipline, or equivalent work experience.
• 0-2 years of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience.

• 0-2 years of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience.

Occupation Demands:

Work is performed in an office. 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. Occasionally walks. Occasionally bends and twists neck. Occasionally drives to site locations and occasional travel within the United States. 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. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Location: Research Triangle Park, NC

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