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.
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 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)
- Radiopharmaceutical experience
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview
Indianapolis - RayzeBio - IN: $134,505 - $162,988
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefits
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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.
- Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
RayzeBio and Bristol Myers Squibb
RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
Supporting People With Disabilities
BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.
R1599491 : Manager, Regulatory Project Management
