Manager, Regulatory Operations and Publishing

🕒 August 5

🇺🇸 United States – Remote

💵 $119.1k - $144.3k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 51%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• 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 for accuracy, consistency, completeness, and compliance • Manage submission execution activities, including deliverable tracking, timeline coordination, submission readiness assessments, and stakeholder communication • Coordinate with external submission vendors to support timely and high-quality submission delivery • Provide technical support to authoring teams using StartingPoint templates • Support reference management activities using 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 • 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

🎯 Requirements

• 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

🏖️ Benefits

• Additional discretionary incentive cash and stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life and disability insurance offerings • Flexible Time Off (FTO) without a set accrual limit for U.S.-based exempt employees, subject to manager approval • 11 paid company holidays each year • 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees in Puerto Rico, subject to manager approval • 3 optional holidays for non-exempt employees, RayzeBio employees, and employees in Puerto Rico • Paid sick leave, depending on eligibility • Up to two paid volunteer days per year, depending on eligibility • 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 for eligible employees • Workplace accommodations/adjustments and ongoing support for people with disabilities