Manager, Regulatory Operations and Publishing

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.

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

- 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.

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.

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.

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 .

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BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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