Grifols Shared Services North America, Inc Regulatory Affairs Specialist - Licensing in RTP, North Carolina
Regulatory Affairs Specialist- Licensing
Determine and execute actions necessary for BLA License supplements and other regulatory submissions to ensure that Grifols is following federal, state, and local licensing and other regulatory requirements, and that business objectives are met.
Responsibilities include but are not limited to:
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
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
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.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Req ID: 172747