Note: The job is a remote job and is open to candidates in USA. RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is hiring a Manager, Regulatory Operations and Publishing to manage regulatory submission operations and publishing. The role oversees document formatting, PDF publishing, technical quality control, submission execution, vendor coordination, and regulatory operations processes.
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
- Wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance offerings, subject to the terms and conditions of the applicable plans and eligibility.
- For U.S.-based exempt employees: Flexible Time Off (FTO), providing paid time off without a set accrual limit, subject to manager approval, and 11 paid company holidays each year.
- For RayzeBio employees: 160 hours of paid vacation annually for new hires, subject to manager approval; 11 paid company holidays; and 3 optional holidays.
- Depending on eligibility: 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.
- For eligible employees: an annual Global Shutdown between Christmas Day and New Year's Day.
- Remote work.
Company Overview
Company H1B Sponsorship