Manager, Regulatory Operations and Publishing
Bristol Myers Squibb•San Diego, CA
•$134,505 - $162,988•Remote
About The Position
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/
Requirements
- 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.
Nice To Haves
- Experience with Accenture StartingPoint Templates and Veeva RIM preferred
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.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Manager
