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Upstream Bio · 3 hours ago

Regulatory CMC Manager

Waltham, MA

Full-time

Onsite

Mid, Senior Level

$146K/yr - $178K/yr

5+ years exp

Upstream Bio is a public company based in Waltham, MA, focused on developing innovative treatments for severe asthma and chronic rhinosinusitis. The Regulatory CMC Manager will influence global regulatory strategies and ensure compliance with regulatory requirements throughout the product lifecycle.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Prepare, review, and submit high-quality CMC sections of regulatory documents including:

INDs/CTAs, BLAs/MAAs, supplements, and post-approval variations

Responses to health authority questions related to CMC topics

Contribute to the development of global CMC regulatory strategies and submission timelines in collaboration with internal colleagues and external CROs/CMOs for investigational and/or commercial products

Collaborate closely with Technical Operations and Quality teams to ensure regulatory requirements are met throughout product lifecycle

Perform regulatory assessment and guidance on product compliance topics including change controls, deviations, site inspections, and GMP investigations

Participate effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects

Participate in regulatory agency meetings (e.g., FDA, EMA) preparation and support

Maintain awareness of global CMC regulatory requirements and trends; proactively assess impact to company products and processes

Qualification

Regulatory AffairsCMC developmentECTD dossiersBiopharmaceutical industryRegulatory guidelinesPlanningPrioritizationMedical devices experienceCollaborationCommunication

Required

Bachelor's degree in Biology, Chemistry, Pharmacy or another related life-science field with 5–8 years of relevant experience in Regulatory Affairs or CMC within the biopharmaceutical industry

Solid understanding of CMC development for biologics

Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines

Experience in the preparation, including writing, of CMC modules (3.2.S / 3.2.P) of eCTD dossiers for early-phase IND/CTA and/or late-stage BLA/MAA submissions

Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner

Strong sense of planning and prioritization and the ability to work with all levels of management