Manager, Regulatory Project Management

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

Manager, Regulatory Affairs Project Management

Background

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC), breast cancer, and hepatocellular carcinoma (HCC).  Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Job Description

The Manager, Regulatory Project Management is responsible for planning, executing, and driving regulatory submissions and regulatory project activities across clinical and nonclinical programs. This role manages cross‑functional timelines, deliverables, and communication to ensure high‑quality, on‑time regulatory submissions in alignment with program and organizational objectives. The position reports to the Head of Regulatory Project Management.

Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

• Project Planning and Execution of Regulatory Submissions
• Lead the planning, coordination, and execution of regulatory submissions and activities (e.g., INDs and amendments, CTAs, NDAs, MAAs, IMPDs, briefing packages, RFIs).
• Develop, maintain, and proactively manage detailed regulatory project timelines and schedules.
• Monitor project progress, identify risks or issues, and escalate proactively with proposed mitigation strategies.
• Cross‑Functional Communication and Coordination
• Serve as the primary regulatory project management point of contact for assigned submissions.
• Communicate project status, risks, and progress to internal stakeholders and leadership.
• Collaborate closely with Program Management to ensure regulatory timelines align with integrated program timelines and expectations.
• Facilitate cross‑functional meetings and ensure clarity of roles, responsibilities, and deliverables.

Documentation and Reporting

• Prepare and maintain regulatory submission trackers and project dashboards.
• Document key milestones, decisions, and action items.
• Provide regular, clear status updates to Regulatory Affairs leadership and cross‑functional teams.

Education and Experience

• Bachelor’s degree or higher in a scientific or related discipline.
• Minimum of 5–7 years of experience in regulatory affairs and/or project management within the pharmaceutical or biotechnology industry.
• Hands‑on experience supporting or leading major global regulatory submissions; NDA filing experience preferred.
• Experience supporting oncology development programs.
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Skills and Qualifications

• Flexibility and adaptability in a fast‑paced, dynamic development environment.
• Strong decision-making skills and ability to navigate ambiguous situations
• Demonstrated record of strong communication and teamwork in a cross‑functional environment.
• Highly organized with the ability to manage multiple