Job Description
About Us
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
The Regulatory Information Manager will support the development of traceable systems, processes, and tools used to collect, manage, and track regulatory information and data throughout the lifecycle of Dianthus products, and oversee the management of all data related to regulatory matters. The successful candidate will help ensure a centralized, structured approach to regulatory submissions compliance with global authority commitments and expectations, and support inspection readiness.
You will serve as a critical link between regulatory affairs and the rest of R&D to ensure that information, such as the status of submissions and knowledge gained from previous health authority queries, is accurate and up to date to support strategic decision-making.
This is a unique opportunity to join a growing organization with an expanding pipeline, and to play an integral role in the in the global development of all programs. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key 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
Experience
- 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
