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Dianthus Therapeutics, Inc. · 3 months ago

Senior Director, Regulatory Combination Product

Waltham, MA

Full-time

Onsite

Director/Executive

Dianthus Therapeutics, Inc. is developing innovative therapies for severe autoimmune diseases. The Senior Director, Regulatory Combination Product, will be responsible for ensuring regulatory compliance for biologics-device combination products throughout their development lifecycles, collaborating with various teams to support product development and commercialization.

BiopharmaBiotechnologyHealth Care

Responsibilities

Develop comprehensive strategies that address both biologic and device components and align with corporate goals and regulatory expectations

Provide guidance for plans and protocols for compatibility studies, design verification studies and functional stability studies, and contribute to the design of human factor studies and usability testing

Interpret regulatory regulations, standards, directives, guidelines and advise Development, Technical Operations, and Quality on their applicability to and impact on product development projects

Deliver strategic input to Design Control processes and documentation, ensuring alignment with health authority and notified body requirements and global technical standards. Review DHF documentation from a regulatory perspective

Design and execute effective submission strategies for device-related dossier components (INDs/CTAs, marketing applications, and post-approval changes) in collaboration with SMEs

Conduct precedent research to ensure creation of state-of-the-art studies

Influence cross-functional decision-making without direct authority, operating effectively in a matrixed environment

Perform assessment of change controls to identify and mitigate regulatory risks

Lead interactions with health authorities and notified bodies

Help manage device-related regulatory information in company systems

Support for other Regulatory CMC activities

Qualification

Regulatory complianceCombination products experienceBiologics experienceISO standards knowledgeGMP requirements understandingInfluencing skillsCommunication skillsStrategic acumenCollaboration skills

Required

A bachelor's degree in a scientific/engineering discipline

Experience as regulatory lead in pharmaceutical, biotechnology, or medical device industries, specifically with combination product filings

Strong knowledge of and broad experience with regulations, standards, directives, guidelines and requirements related to the use of combination products in global clinical studies and commercial registration

Proven track record in late‑stage development of combination products

In-depth understanding of ISO and ASTM standards relevant to combination products

Solid understanding of current industry trends and regulatory expectations associated with combination products

Good understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics

Strategic acumen, collaboration, influencing skills, and communication skills are important for success