Regulatory Affairs Manager

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: 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 elevate 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 years of experience in regulatory affairs, project management, life sciences, or healthcare. Hands-on experience supporting or leading major global regulatory submissions; NDA filing experience preferred. Experience supporting oncology development programs. Skills and Qualifications Strong interpersonal skills with the ability to build and maintain effective cross‑functional relationships. 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. 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. Applies AI to improve team execution and decision-making. Physical Demands While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision. Work Environment The noise level in the work environment is usually low to moderate. 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. Benefits Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit 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 View email address on click.appcast.io . 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: 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 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 View email address on click.appcast.io . 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. R1605576 : Manager, Regulatory Affairs Project Management #J-18808-Ljbffr