Regulatory Affairs Specialist
They are a global animal health company. Through their commitment to the science of healthier animals, they offer a wide range of veterinary products and services.
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). Your job includes both data migration to Alexx, and further responsibilities:
- 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.
All work is done in accordance with EPA, FDA GxP, OECD GLP, USDA, and VICH regulations and guidelines to ensure document integrity.
- 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.
- Expertise in Document Management Systems (e.g. Veeva Vault), or repositories like SharePoint is preferred.