Kristal L. Sheldon

About Kristal L. Sheldon

HIGHLIGHTS OF QUALIFICATIONS • Proficient in multiple computer software programs…

Experience

1. Regulatory Operations

   Biohaven

   Jul 2021 — Present

   Actively engages with multiple stakeholders throughout the company regarding document processing procedures and communicates the benefit of strategies which support the publishing and broader regulatory team.• Assists in the implementation of planned document processes which appropriately utilize approaches including, but not limited to, communicating enhanced digital system capabilities, and/or other service offerings which optimize the authoring team experience and document submission timelines.• Serves as a lead contributor to the ongoing development, maintenance, and enhancement of internal guides for document processing and publishing.• Liaise with assigned Dossier Managers to provide quality control support of dossiers prior to submission to health authorities• Supports authors and new publishers by providing guidance and on the spot training for the Regulatory Information System (Veeva Rim Vault), MS Office (ie: Word, Adobe) and Health Authority document requirements.• Member of the change control committee for Veeva RIM Vault. Review requests and collaborate with members to implement requested changes to improve system improvements for document writing, review, and approval for all regulatory documents.• Lead project assignment meetings to track large project request completion and ensure fair distribution of workload.• Partners and actively collaborates with internal department designees to ensure awareness of and alignment with ongoing document processing activities and requirements.

Education

• Orange Coast College

  Associate Degree, Liberal Arts

• East Carolina University

  Bachelor of Science - BS, Communication, General

  2018 — 2022