Senior Director, Regulatory Combination Product

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October 3

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Dianthus Therapeutics, Inc.

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Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

2 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

📋 Description

• Play a critical role in defining and driving regulatory compliance of biologics-device combination products across their development lifecycles. • Collaborate with device development, device quality, and CMC Team SMEs to support the development and commercialization of therapeutic products for rare diseases. • 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. • Design and execute effective submission strategies for device-related dossier components in collaboration with SMEs. • Conduct precedent research to ensure creation of state-of-the-art studies. • 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 other Regulatory CMC activities.

🎯 Requirements

• 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.