Manager, Regulatory Operations and Publishing

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $134.5k - $163k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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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 • Format complex documents according to company standards to optimize PDF rendering • Generate submission-ready PDFs compliant with regulatory guidance, eCTD requirements, and internal standards • Perform technical QC of submission documents and published submissions • Manage deliverable tracking, timeline coordination, submission readiness assessments, and stakeholder communications • Coordinate with external submission vendors • Provide technical support to authoring teams using StartingPoint templates • Support reference management in EndNote or other tools • Partner with Regulatory Affairs and cross-functional teams to resolve formatting, publishing, and QC issues • Support creation and maintenance of records and documents in Veeva Vault RIM and other systems • Support development and improvement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards • Maintain current knowledge of FDA, ICH, and other applicable electronic-submission and document standards

🎯 Requirements

• Bachelor’s degree with 4+ years of Regulatory Operations experience • Experience with Accenture StartingPoint Templates and Veeva RIM preferred • 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 and 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 • Ability to sit, reach with hands and arms, and talk or hear regularly • Ability to occasionally lift and/or move up to 15 pounds • Close vision and distance vision required

🏖️ Benefits

• Additional incentive cash and stock opportunities (based on eligibility) • Medical, pharmacy, dental, and vision care • BMS Well-Being Account • BMS Living Life Better • 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 • Flexible time off (unlimited, with manager approval) for eligible US exempt employees • 11 paid national holidays for eligible US exempt employees • 160 hours annual paid vacation for eligible Phoenix, AZ, Puerto Rico, and RayzeBio employees • 3 optional holidays for eligible Phoenix, AZ, Puerto Rico, and RayzeBio employees • Unlimited paid sick time, based on eligibility • Up to 2 paid volunteer days per year, based on eligibility • Summer hours flexibility, based on eligibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs • Annual Global Shutdown between Christmas and New Year’s Day