Regulatory Affairs Program Manager
avetix engineeringNew York, NY
Regulatory Affairs Program Manager
avetix engineeringNew York, NY
today
Industries
Research and Development in Biotechnology (except Nanobiotechnology)Biological Product (except Diagnostic) ManufacturingPharmaceutical Preparation ManufacturingAbout the role
A publicly traded, commercial-stage biopharmaceutical company is developing next-generation immunotherapies designed to harness the body's own immune system against cancer and infectious disease. Their lead product - an FDA Breakthrough Therapy for non-muscle invasive bladder cancer - is already changing outcomes for patients. They're now looking for a Regulatory Affairs Program Manager to help drive the next wave of approvals.
What you'll do:
- Lead cross-functional regulatory programs from strategy through execution — setting timelines, milestones, and risk-mitigation plans
- Act as the regulatory point of contact across R&D, Clinical, Quality, Manufacturing, and Commercial
- Track regulatory intelligence and translate changing global requirements into clear, actionable strategy
- Own SOPs and process standardization, and report program status to senior leadership
What you'll bring:
Bachelor's degree in sciences, business, or project management, with 5+ years of progressive experience 4+ years in regulatory affairs within pharma, biologics, or medical devices (preferred)3+ years managing complex, multi-regional regulatory programs (preferred) Strong cross-functional collaboration skills and a track record of delivering on schedule This is a chance to join a publicly traded biopharma company at a pivotal growth stage - working at the intersection of science, strategy, and execution to bring transformative therapies to patients faster.
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JOB OVERVIEW
Experience level
Manager
Location
New York, NY
Occupation
Regulatory Affairs Managers
Industry
Research and Development in Biotechnology (except Nanobiotechnology)
Posted
today
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