You haven't searched anything yet.
Upstream Bio is developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing that has raised $400M from high-quality investors. We are developing a monoclonal antibody targeting validated biology and are focused on our two Phase 2 studies in asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) in 2024. Our offices are in Waltham, MA. We have a hybrid working model, with Tuesdays-Thursdays in the office and Mondays and Fridays flexible to work remotely if desired.
The Associate Director/Director, Regulatory CMC will be responsible for leading the regulatory Chemistry, Manufacturing, and Controls (CMC) strategy for the company's biopharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory requirements and support the development, approval, and commercialization of innovative therapies. The successful candidate will provide expertise in regulatory CMC, guide submission strategies, and maintain regulatory documentation to support product lifecycle management.
Key Responsibilities:
Regulatory Strategy and Submissions:
Regulatory Compliance:
Cross-functional Collaboration:
Documentation and Communication:
Qualifications:
Full Time
$114k-147k (estimate)
08/24/2024
09/22/2024