Offer summary

Qualifications:

Bachelor's degree required., Experience in the biotech or pharmaceutical industry is essential, with a preference for rare disease or neurology product experience., Strong understanding of regulatory requirements for drug development and approval is necessary., Excellent written and verbal communication skills, along with strong organizational and project management abilities..

Key responsibilities:

Ensure planning, tracking, and alignment of regulatory submissions, including IND applications and clinical trial applications.

Represent regulatory affairs at study management team meetings and liaise with CROs for country requirements.

Facilitate health authority query management and prepare submission components in line with regulatory strategies.

Maintain records of communications with health authorities and assist global regulatory leads with execution of regulatory strategies.

Job description

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

The Manager, Regulatory Affairs will support global development programs in collaboration with key stakeholders.

Reporting to the Senior Vice President, Regulatory Affairs, you will support regulatory activities and contribute to department initiatives. This position will focus on clinical trial applications (CTAs), regulatory planning, and facilitating global submissions as we work toward bringing innovative therapies to market.

This is a unique opportunity to join a growing organization with an expanding pipeline, and to play an integral role in the creation and implementation of regulatory strategies from early development through marketing approval. 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

Ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions, including Investigational New Drug (IND) applications, clinical trial applications, IND/CTA amendments, notifications, and reports.
Represent regulatory at study management team meetings.
Liaise with CRO to ensure that a comprehensive list of country requirements and potential challenges is generated and communicated to team.
Facilitate health authority query management and submission of responses, including scheduling of cross-functional team meetings.
Contribute to preparation of submission components in conformance with regulatory requirements and strategies to ensure high quality and timely submissions.
Maintain accurate records of communications with health authorities and track application status.
QC regulatory components of Trial Master Files for accuracy and completeness
Create and manage health authority query and commitment trackers.
Assist global regulatory leads with execution of regulatory strategies.
Build and apply knowledge of FDA, EU Clinical Trial Regulation, and other international regulatory requirements for clinical trials to determine potential risks, impacts, and mitigations.
Support departmental initiatives, including process and infrastructure development.

Experience

Bachelor's degree required.
Experience within the biotech or pharmaceutical industry required; rare disease and/or neurology product experience a plus
Understanding of regulatory requirements for drug development and approval
Demonstrated problem-solving ability, flexibility, and teamwork
Experience in preparing and submitting CTAs, INDs, and other regulatory documents
Excellent written and verbal communication skills with attention to detail
Strong organizational and project management skills
Good interpersonal skills and the ability to work collaboratively across departments and with external partners