[Remote] Manager, Regulatory Operations and Publishing

Note: The job is a remote job and is open to candidates in USA. RayzeBio, a subsidiary of Bristol Myers Squibb, is dedicated to developing transformative radiopharmaceutical therapies for cancer patients. The Manager of Regulatory Operations and Publishing will oversee regulatory submission operations, ensuring compliance and quality in health authority submissions.

Responsibilities

• 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

Skills

• Bachelor's degree with 4+ years of Regulatory Operations experience
• 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
• Experience with Accenture StartingPoint Templates and Veeva RIM preferred

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).
• 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
• Survivor support
• 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.

Company Overview

• At Bristol Myers Squibb, we work every day to transform patients’ lives through science. It was founded in 1887, and is headquartered in New York, New York, USA, with a workforce of 10001+ employees. Its website is http://www.bms.com.

Company H1B Sponsorship

• Bristol Myers Squibb has a track record of offering H1B sponsorships, with 63 in 2026, 247 in 2025, 278 in 2024, 231 in 2023, 180 in 2022, 181 in 2021, 169 in 2020. Please note that this does not guarantee sponsorship for this specific role.