Regulatory Affairs Specialist
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Regulatory Affairs Specialist

Ref: 14563244

Toegevoegd op 14 May 2020
Contract type
Detachering

Functieprofiel

  • Review and identify documents to determine the appropriate classifications of Biologics R&D, Clinical, CMC, Drug Discovery, Preclinical, Regulatory, Statistics, etc.
  • Identify the attributes from the documents and input the corresponding metadata into Alexx.
  • Request new Study Numbers, new Products, new Project Codes, or new CRO Names using the Alexx Portal, when necessary.
  • Contact personnel from the appropriate business unit to obtain information to correctly identify documents, as needed.
  • Assure close working relationship with stakeholders within R&D.
  • Review documents and metadata for clarity and completeness prior to sending for approval.
  • Assist in execution of UATs (User Acceptance Testing) for Alexx updates, if needed.
  • Will assist with other Veeva Vault tasks and other duties as needed.

This will satisfy the requirements according to EPA, FDA GxP, OECD GLP, USDA, and VICH regulations and guidelines to ensure document integrity.

Bedrijfsprofiel

Alexx is an Animal Health Global GxP Document Management System used to store Regulatory relevant documents across R&D. This system is run within the Veeva Vault Platform (A cloud-based software).

Alexx Migration

o Migrate and reclassify documents both paper and electronic originals (Protocols, Reports, Raw Data, Literature Articles, Biologics, CMC Documents, Batch Release Documents, Detailed and Critical Summaries, Sponsor Reports, etc.).

o Migration of documents can include: external Regulatory related documents from SharePoint sites, network shares (i.e. shared drives), and electronic media.

o Upload (scan if needed) and classify documents to be made viewable in Alexx.

o Reclassify already existing metadata on documents in Alexx from temporary storage to the production environment.

Functie-eisen

  • Bachelor’s degree (or equivalent work experience) with 7 years’ experience in a related field and/or industry.
  • Knowledge of scientific R&D documents within the Animal Health or Life Science industry is required.
  • Knowledge and understanding of EPA, FDA GxP, FDA CFR 21 Part 11OECD GLP, USDA, and VICH regulations and guidelines is required.
  • Knowledge of submission related documentation is a plus.
  • Must have prior experience with reading and comprehension of Biologics, Clinical and/or Preclinical study related documentation.
  • Must have strong communication, organization, and writing skills with the ability to multi-task.
  • Demonstrated ability to work independently and as part of a team with strong attention to detail and accuracy.
  • Ability to apply strategic and analytical thinking to a project.
  • Demonstrated ability to focus and drive consistency in a fast-paced environment.
  • Expertise in Document Management Systems (Veeva Vault) and/or repositories like SharePoint is preferred.
  • Expertise in Office related software (Microsoft Excel, Microsoft Word, Acrobat, etc.).

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