Senior Manager, Learning & Technology Operations, Compliance
Cars Commerce
Senior Director, Regulatory Combination Product
Dianthus Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory compliancecombination productscompatibility studiesdesign verification studiesfunctional stability studieshuman factor studiesusability testingsubmission strategieschange control assessmentlate-stage development
Soft skills
strategic acumencollaborationinfluencing skillscommunication skills
Certifications
bachelor’s degree in scientific disciplinebachelor’s degree in engineering discipline
