Manager, Regulatory Operations and Publishing

Life at BMS 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/ Job Title: Manager, Regulatory Operations and Publishing Department: Regulatory Location: Remote FLSA Status: Exempt Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Manage day-to-day regulatory submission operations activities to ensure high-quality, timely, and compliant health authority submissions. Format complex documents according to company formatting standards to optimize PDF rendering and limit manual publishing of PDF documents. Generate submission-ready PDFs in compliance with regulatory guidance, eCTD requirements, and internal PDF publishing standards. Perform technical QC of submission documents and published submissions to ensure accuracy, consistency, completeness, and compliance with submission requirements. Manage submission execution activities, including deliverable tracking, timeline coordination, submission readiness assessments, and communication with Regulatory Affairs and cross-functional stakeholders to ensure timely submission delivery. Coordinate with external submission vendors to support timely and high-quality submission delivery. Provide technical support to authoring teams on the use of StartingPoint templates. Support reference management activities, including maintaining references in EndNote or other reference management tools. Partner with Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve formatting, publishing, and QC issues. Support creation and maintenance of data, records, and documents in Veeva Vault RIM and other systems, as applicable. Support development and continuous improvement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards. Maintain current knowledge of FDA, ICH, and other applicable regulatory requirements related to electronic submissions and document standards. Education and Experience Bachelor’s degree with 4+ years of Regulatory Operations experience Experience with Accenture StartingPoint Templates and Veeva RIM preferred Skills and Qualifications Demonstrated expertise in Microsoft Word formatting, PDF publishing, and submission document preparation. Strong understanding of eCTD submission structure, PDF specifications, bookmarks, hyperlinks, file naming, and submission-ready document standards. Experience performing technical quality control of regulatory submissions and published eCTD sequences. Highly detail-oriented, with strong focus on accuracy, consistency, and quality. Strong organizational skills, with the ability to manage multiple concurrent submissions and competing priorities. Ability to troubleshoot complex document formatting and PDF publishing issues. Ability to work independently and follow tasks through from start to finish. Strong communication and interpersonal skills. Ability to collaborate effectively with internal teams and external vendors. Proactive, professional, and confident. Excellent professional ethics and integrity. 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. #LI-REMOTE We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. Compensation Overview: Remote - United States - US: $134,505 - $162,988 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance. Benefits: Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits 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 qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: 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 this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account. R1605078 : Manager, Regulatory Operations and Publishing