Dianthus Therapeutics
Pharmaiotech
RegulatoryInformationManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Regulatory Information Manager at Dianthus Therapeutics. Skills: Regulatory Information Management System, document management, data management, regulatory submissions. 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. oversee the management of all data related to regulatory matters”
What You'll Achieve.
ensure a centralized, structured approach to regulatory submissions compliance with global authority commitments and expectations; support inspection readiness; 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
Industry & Context.
Demonstrated problem-solving ability
What They're Looking For.
Must Have
Scientific Bachelor's degree, 2-3 years’ experience in Pharmaiotech industry, Demonstrated organizational skills, self-starter, Aptitude for learning technology and software, Ability to work effectively in a fast-paced, collaborative, and dynamic environment, interpersonal skills and the ability to collaborate effectively with subject matter experts, Demonstrated problem-solving ability, flexibility, teamwork, Excellent communication, writing, and presentation skills, Advanced experience working in MS Office, Adobe Pro, Smartsheet
Nice to Have
Experience working in Regulatory Affairs department an asset, Previous experience working in Veeva RIM an asset
What You'll Do.
support the development of traceable systems
and tools used to collect
and track regulatory information and data throughout the lifecycle of Dianthus products
oversee the management of all data related to regulatory matters
structured approach to regulatory submissions compliance with global authority commitments and expectations
support inspection readiness
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
support 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
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
How You'll Work.
Team & Collaboration
serve as a critical link between regulatory affairs and the rest of R&D; collaborate effectively with subject matter experts
Communication Scope
Excellent communication; writing; presentation skills
Process & Methodology
Project management mindset
Full 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 Responsibili
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