Dianthus Therapeutics - Regulatory Information Manager
Requirements
• Scientific Bachelor's degree and 2-3 years’ experience in Pharma/Biotech industry • Demonstrated strong organizational skills and a self-starter • Project management mindset • Aptitude for learning technology and software • Ability to work effectively in a fast-paced, collaborative, and dynamic environment. • Experience working in Regulatory Affairs department an asset • Previous experience working in Veeva RIM an asset • Strong interpersonal skills and the ability to collaborate effectively with subject matter experts. • Demonstrated problem-solving ability, flexibility, and teamwork. • Excellent communication, writing, and presentation skills • Advanced experience working in MS Office, Adobe Pro, and Smartsheet
Responsibilities
• Work across the regulatory team supporting all document management activities • Support implementation and maintenance of Regulatory Information Management System across all programs. • Archive regulatory submission documents, content plans and health authority queries for easy searching and retrieval • Own and maintain document repositories, trackers and dashboards, providing up to date, accurate information as a communication tool within R&D • Authoring of departmental documents including SOPs to support the systems and processes used in Regulatory Affairs and Regulatory Development Plans • Support departmental initiatives, including process and infrastructure development, regulatory intelligence, and budgeting
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