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Grifols Shared Services North America, Inc Regulatory Records System Coordinator in Durham, North Carolina

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

Maintain regulatory record filing systems for North American Regulatory Affairs for Plasma Operations in both hard copy and electronic filing formats, process incoming and outgoing correspondence, coordinate the prompt payment of all licensing and accreditation fees, and assist Regulatory Affairs Specialists to meet business objectives.

Primary Responsibilities:

  • Maintain regulatory record filing systems for both hard copy and electronic formats.

  • Ensure that all regulatory records are properly filed and accessible.

  • Assist in maintaining SOPs that describe the Regulatory Affairs filing system.

  • Submit and track outgoing regulatory correspondence; direct incoming correspondence to responsible parties

  • Respond to requests for records by researching and reviewing internal documentation, including the retrieval of documents from off-site storage.

  • Communicate with internal customers at headquarters, laboratories, and plasmapheresis centers regarding regulatory records.

  • Process and track all invoices to ensure prompt payment (e.g., licensing, accreditation).

  • Serve as primary contact with Accounts Payable.

  • File and archive submissions electronically and in hardcopy, share appropriate correspondence with the plasmapheresis center and other interested parties.

  • 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 supplements and reports.

  • Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives.

Requirements:

  • Bachelor’s degree in a relevant discipline, or equivalent work experience.

  • 0 to 1 year of related technical and/or regulatory experience in pharmaceutical or blood industry or an equivalent combination of education and experience.

EEO Minorities/Women/Disabled/Veterans

Req ID: 284488

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