Manager, Regulatory Operations and Publishing
Bristol Myers Squibb
September 02, 2026
Remote
United States
Operations
Job Title: Manager, Regulatory Operations and Publishing
Job Responsibilities
- Manage day-to-day regulatory submission operations to ensure high-quality, timely, compliant submissions.
- Format complex documents to company standards for optimized PDF rendering and reduced manual publishing.
- Generate submission-ready PDFs compliant with regulatory guidance, eCTD requirements, and internal standards.
- Perform technical QC of submission documents and published submissions for accuracy, consistency, completeness, and compliance.
- Manage submission execution (deliverable tracking, timeline coordination, submission readiness assessments, and communication with Regulatory Affairs and cross-functional stakeholders).
- Coordinate with external submission vendors.
- Provide technical support to authoring teams on StartingPoint templates.
- Support reference management (e.g., EndNote or other tools).
- Partner across Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve formatting/publishing/QC issues.
- Support document/record creation and maintenance in Veeva Vault RIM and other systems as applicable.
- Support development/continuous improvement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards.
- Maintain knowledge of FDA, ICH, and applicable e-submission/document standards.
Education & Experience
- Bachelor’s degree with 4+ years of Regulatory Operations experience.
- Experience with Accenture StartingPoint Templates and Veeva RIM preferred.
Skills & Qualifications
- Expertise in Microsoft Word formatting, PDF publishing, and submission document preparation.
- Strong understanding of eCTD structure and PDF specifications (bookmarks, hyperlinks, file naming, submission-ready standards).
- Experience performing technical QC of regulatory submissions/eCTD sequences.
- Detail-oriented; strong organizational skills; ability to troubleshoot complex formatting/PDF publishing issues.
- Independent execution; strong communication and collaboration; ethics and integrity.
Benefits (as stated)
- U.S. exempt employees: Flexible Time Off (FTO) + 11 paid company holidays.
Compensation (as stated)
- Remote (United States): $134,505–$162,988.
Job Responsibilities
- Manage day-to-day regulatory submission operations to ensure high-quality, timely, compliant submissions.
- Format complex documents to company standards for optimized PDF rendering and reduced manual publishing.
- Generate submission-ready PDFs compliant with regulatory guidance, eCTD requirements, and internal standards.
- Perform technical QC of submission documents and published submissions for accuracy, consistency, completeness, and compliance.
- Manage submission execution (deliverable tracking, timeline coordination, submission readiness assessments, and communication with Regulatory Affairs and cross-functional stakeholders).
- Coordinate with external submission vendors.
- Provide technical support to authoring teams on StartingPoint templates.
- Support reference management (e.g., EndNote or other tools).
- Partner across Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve formatting/publishing/QC issues.
- Support document/record creation and maintenance in Veeva Vault RIM and other systems as applicable.
- Support development/continuous improvement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards.
- Maintain knowledge of FDA, ICH, and applicable e-submission/document standards.
Education & Experience
- Bachelor’s degree with 4+ years of Regulatory Operations experience.
- Experience with Accenture StartingPoint Templates and Veeva RIM preferred.
Skills & Qualifications
- Expertise in Microsoft Word formatting, PDF publishing, and submission document preparation.
- Strong understanding of eCTD structure and PDF specifications (bookmarks, hyperlinks, file naming, submission-ready standards).
- Experience performing technical QC of regulatory submissions/eCTD sequences.
- Detail-oriented; strong organizational skills; ability to troubleshoot complex formatting/PDF publishing issues.
- Independent execution; strong communication and collaboration; ethics and integrity.
Benefits (as stated)
- U.S. exempt employees: Flexible Time Off (FTO) + 11 paid company holidays.
Compensation (as stated)
- Remote (United States): $134,505–$162,988.