Manager, Regulatory Project Management

Bristol Myers Squibb • Indianapolis, IN

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About The Position

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.

Requirements

• 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.
• 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 complex projects simultaneously.
• Ability to think through projects of varying complexity and execute independently from initiation through completion.
• Strong written and verbal communication skills.
• Strong interpersonal skills with the ability to build and maintain effective cross‑functional relationships.
• Working knowledge of relevant global regulations, guidances, and regulatory standards.
• Professional, proactive, and confident approach with high ethical standards.
• Experience with all phases of clinical development
• Demonstrable proficiency in project timeline and Gannt chart software (eg, MS Project, Smartsheet), MS Office (e.g., Outlook, Word, PowerPoint, Excel, and Teams)

Nice To Haves

• Radiopharmaceutical experience

Responsibilities

• 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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager