Navigator Medicines, Inc. · 9 hours ago
Associate Director, Regulatory Affairs
United States
Full-time
Remote
Lead/Staff, Director/ExecutiveNavigator Medicines is a clinical-stage biopharmaceutical company focused on advancing biologics for targeted immune regulation. The Associate Director, Regulatory Affairs is responsible for developing regulatory strategies, ensuring compliance with FDA and global expectations, and supporting the clinical trial application approval process.
BiotechnologyLife Science
Responsibilities
Creating innovative global regulatory strategies for biologics throughout assigned product's lifecycle
Collaborating with cross-functional teams to ensure regulatory strategies align with corporate goals and evolving regulatory expectations
Ensuring regulatory compliance with evolving FDA and global regulatory expectations
Provides strategic input on regulatory requirements, including benefit/risk assessments, and recommends regulatory solutions during early-to-late stage product development
Champions and cultivate a culture of quality within a diverse working environment
Brings unstoppable energy and enthusiasm to delivering top-quality results in a fast-paced, fun, and dynamic environment
Qualification
Required
Have a working knowledge of regulatory requirements specific to key regions such as the US, Canada, and EU, and have a general awareness of current global trends in Regulatory Affairs
Recognized as a leader, crew member, and possess a cross-functional collaborative skill set
Excellent oral and written communication and negotiation skills with strong attention to detail and clarity
Company
Navigator Medicines, Inc.
Navigator Medicines is a clinical-stage biotechnology company advancing bi-specific antibodies anchored in OX40L inhibition.
Founded in 2024
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$100M2024-08-27Series A· $100M
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